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Analytical Laboratories, Inc.

Quality Manual

Director: Michael Moore

Quality Manager: Brian McGovern

Deputy Quality Manager: James Hibbs

Date of Issue: November 15, 2013

Uncontrolled Copy:

rd
1804 North 33 St. ● Boise, ID. 83703 ● Ph: (208) 342-5515 ● Fax: (208) 342-5591
Website: http://www.analyticallaboratories.com ● 1-800-574-5773
Quality Manual
This Quality Manual meets the requirements of ISO 17025 and ISO 9001. This Quality
Manual is confidential and assigned as outlined below.

Issued to:

Controlled Copy
Uncontrolled Copy

Copyright © 2005 SHOQ Quality Assurance Manuals Inc.

All rights reserved. The use and copying of this product is subject to a license agreement. Any other use is
prohibited. No part of this book may be reproduced in any form or by any means, electronic, mechanical,
photocopying, stored in a retrieval system, recording or otherwise, without the prior written permission of
SHOQ Quality Assurance Manuals Inc. No part of this book may be translated into any other language
without the prior written permission of SHOQ Quality Assurance Manuals Inc. Information in this manual
is subject to change without notice and does not represent a commitment on the part of the vendor.
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Table of Contents
0. Introduction

1. Scope and Employee List

2. Normative References
Reference List
Cross-references

3. Terms and Definitions

4. Management Requirements
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of Requests, Tenders, and Contracts
4.5 Sub-contracting of Tests and Calibrations
4.6 Purchasing Services and Supplies
4.7 Service to the Customer
4.8 Complaints
4.9 Control of Nonconforming Testing and Calibration work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Management Reviews

5. Technical Requirements
5.1 General
5.2 Personnel
5.3 Accommodation and Environmental Conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling of Test and Calibration Items
5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results
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Introduction
Purpose

This Quality Manual contains all the requirements that our laboratory uses to demonstrate
our quality management system, technical competence, and valid results.

Section 4 specifies how we demonstrate sound management and maintain client


satisfaction.

Section 5 specifies how we demonstrate technical competence in our laboratory.

In addition, this Quality Manual outlines how we meet:

¾ ISO 17025
¾ ISO 9001

All personnel are to take an active role in establishing, implementing, and maintaining
our quality management program. We do not separate quality from our daily business.
Quality cannot be something that we do just to pass audits. Quality is integrated into
every facet of the decision-making process in the management of our laboratory and the
science that we practice.

Distribution List

The Quality Manager maintains a distribution list for this Quality Manual.

Revision History
Revision 1 - The Table of Contents was updated to reflect the addition of an Employee
List in Section 1. 11-24-09
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1. Scope
This Quality Manual facilitates:

¾ recognition of technical competence for standardized methods, non-routine methods,


and laboratory-developed methods we perform
¾ inspection and product certification capabilities and/or services we provide
¾ total quality for our administrative and technical systems
¾ audits by clients, regulatory authorities and accreditation bodies
¾ meeting the requirements of ISO 17025 and ISO 9001
¾ client satisfaction
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Revision History
Revision 1 - This section was updated to reflect the addition of an Employee List.
11-24-09

Revision 2 - This section was updated to reflect the current Employee List.
03-16-12

Revision 3 - This section was updated to reflect the current Employee List.
11-14-13
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2. Normative References

Reference List

ISO/IEC 17000, Conformity assessment – Vocabulary and general principles

VIM, International vocabulary of basic and general terms in metrology, issued by BIPM,
IEC, IFCC, ISO, IUPAC, IUPAP and OIML.

ISO 9001:2000 – Quality Management Systems – Fundamentals and vocabulary.

ISO 17025:2005 – General Requirements for the Competence of Testing and Calibration
Laboratories.

Cross-references

This manual is numerically aligned with the international standard ISO 17025. It is
expected that this will prove useful during accreditation audits and expedite the process.

Furthermore, each section cross-references the ISO 9001 standard to assist the laboratory
during the ISO 9001 registration process (if applicable).

For ease of use, each section starts with a brief summation of what the section addresses
and a listing of the quality terminology and key words.
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3. Terms and Definitions

For the purposes of this manual, the following documents and their corresponding
definitions apply: ISO/IEC 17000; ISO/IEC Guide 30; ISO Council Committee on
Conformity Assessment (CASCO); ISO 9000; ISO 5725-1; ISO 17025; AOAC; and
International Vocabulary of Basic and General Terms in Metrology (VIM).

Accreditation – formal recognition of a laboratory by an independent science-based


organization that the laboratory is competent to perform specific tests (CASCO).
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4.1 Organization

The Ten Second Tutorial


This section tells you our laboratory has:

1. Appointed a Quality Manager


2. Organized the workforce to achieve quality
3. Provided adequate resources to ensure quality

Key Words
Quality Manager
Organizational Chart
Authority
Resources
Confidential Information
Proprietary Rights
Responsibilities
Undue Pressure

Cross-references
ISO 17025:2005 Section 4.1
ISO 9001:2000 Section 4.1, 5.1, 5.3, 5.4.1, 5.5.1, 5.5.2, 5.5.3, 6.1,
6.2.1, 6.2.2, 6.3.1, 7.1, 7.5.4
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4.1.1 Legal Identification / Registration


Analytical Laboratories, Inc.
1804 N. 33rd St., Boise, ID. 83703
Phone: (208) 342-5515 Fax: (208) 342-5591
Website: http://www.analyticallaboratories.com

4.1.2 Laboratory Requirements


The departments of Analytical Laboratories, Inc. have been organized to satisfy the needs
of the customer and regulatory authorities and to meet the international standards ISO
17025 and ISO 9001. Analytical Laboratories, Inc. is composed of the following
departments:

Bacteria (Microbiology) Metals


Biomonitoring (WETT) Nutrients
Environmental Chemistry Organics
Food Chemistry Services
Fuels

4.1.3 Scope of Management System


The management system covers activities in the laboratory’s permanent facility. The
fields of activities include:

• Agricultural & Food


• Drinking Water
• Environmental
• Fuels & Lube Oils
• Soils
• Solids / Sludge / Waste
• Wastewater

The laboratory’s scope of tests is listed in the Laboratory Information Management


System (LIMS).

4.1.4 Potential Conflicts of Interest


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Not applicable - the laboratory is not part of a larger organization.

4.1.5 Organization
A) Management and Technical Personnel

Policy:
The laboratory managerial and technical personnel, irrespective of other responsibilities,
have the necessary authority and resources needed to meet the mandates assigned to their
areas.

Details:
Responsibilities are detailed in 4.1.5 (F).

Departures from the organizational and management policies in this manual can only be
approved by the Board of Directors.

Departures from quality management system procedures can only be approved by the
Director and Quality Manager.

Departures from test methods or technical standard operating procedures (SOPs) can only
be approved by the Director, Quality Manager, and area Supervisors.

See also section 5.2.

B) Undue Pressure

Policy:
Management and personnel are to be free from any undue internal and external
commercial, financial and other pressures that may adversely affect the quality of their
work. The integrity of test results is the responsibility of all personnel. Management
ensures that employees are never instructed or forced to alter or falsify data.

Details:
The following list provides some guidelines on how employees avoid conflict of interest
situations. Employees shall not:
falsify records, prepare fraudulent reports, or make false claims
seek or use privileged or confidential company information, or data from any
customer, for any purpose beyond the scope of employment
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conduct non-laboratory business on laboratory time, or use company facilities or


equipment to conduct outside interests in business, unless prior approval has been
obtained
solicit business on their own behalf (rather than the laboratory) from a customer
be employed by, or affiliated with, organizations whose products or services compete
with laboratory products or services
have employment that negatively affects or interferes with their performance of
laboratory duties
compete with the laboratory in the purchase, sale, or leasing of property or goods
allow association, family, or friends to influence business decisions to their benefit -
decisions must be made on a strictly business basis, always in the best interest of the
laboratory
make any decision that provides gains or benefits to the employee and/or others
have personal financial dealings with an individual or company that does business
with the laboratory which might influence decisions made on the laboratory’s behalf

Firm adherence to this code of values forms the foundation of our credibility. Personnel
involved in dishonest activities are subject to a range of disciplinary action including
dismissal.

C) Customer Confidentiality

Policy:
It is the policy of our laboratory to protect the confidential information and proprietary
rights of our customer including the electronic storage and transmission of results.

Details and Procedures:


All employees sign an Employee Confidentiality Agreement. The signed agreement is
maintained by the Quality Manager.

All employees are required to utilize a username and password to access the Laboratory
Information Management System (LIMS) which contains the proprietary and confidential
information for all of Analytical Laboratories clients.

Test results are only released to the customer. Release to someone other than the
customer requires the express permission of the customer, except when the situation
contravenes Idaho or Federal Legislation and the results must be provided to the
appropriate agency. The release of test results to anyone other than the customer requires
the permission of management. Laboratory reports are reviewed for accuracy prior to
release.
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D) Operational Integrity

Policy:
The laboratory will avoid involvement in any activities that would diminish confidence in
its competence, impartiality, judgment, or operational integrity.

Details and Procedures:


To ensure confidence in laboratory operations a formal quality assurance program is
implemented. Technical competence is ensured through check sample programs.
Impartiality is assessed through audits and approvals. Judgment is ensured through the
hiring of qualified personnel and by continuously refining, upgrading, and improving his
or her skills. Operational integrity is reviewed by management on a regular basis at
management review meetings to ensure continued suitability and effectiveness of
laboratory policies and procedures. Any problems are acted on immediately through
corrective action procedures.

E) Organizational Structure

Policy:
The organization and management structure of the laboratory and the relationships
between management, technical operations, support services, and the quality management
system is defined through the aid of an organizational chart.

Details:
Senior management keeps the most current organizational chart on file. An organizational
chart is available with this manual (upon request) as a reference record and is considered
the official record on the date it is marked.

F) Responsibility and Authority

Director
develops primary goals, operating plans, policies, and short and long range objectives
for the laboratory; implements these following Board of Directors’ approval
directs and coordinates activities to achieve profit and return on capital
establishes organizational structure and delegates authority to subordinates
leads the laboratory towards objectives, meets with and advises other executives, and
reviews results of business operations
ensures laboratory adherence and compliance with ISO/IEC 17025
determines action plans to meet the needs of stakeholders
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represents organization to major customers, government agencies, shareholders, and


the public

Quality Manager
ensures that the Quality Management System is established, implemented and
maintained in accordance with the ISO 9001 and ISO 17025 standards
manages the internal audit program
coordinates laboratory accreditation activities
handles the maintenance and distribution of the Quality Manual and associated
documents
maintains a master list of current versions of quality documentation
trains personnel on Quality Management System activities
monitors the Quality Management System
reports on the performance of the Quality Management System to senior management
for review and as a basis for improvement of the Quality Management System
supervises the laboratory’s inter-laboratory proficiency testing program
maintains current job descriptions

Supervisors
is/are knowledgeable of the scope of all processes under their supervision
provides the necessary resources (personnel, equipment, supplies) for the quality
assurance program, in order to ensure confidence in the laboratory’s results
ensures equipment is maintained and calibrated, reporting all deficiencies (e.g.,
equipment malfunctions) in the appropriate manner
ensures personnel are trained for the duties they perform - includes substitutes when
regular personnel are absent
maintains records and manages all aspects of testing activities
ensures laboratory adherence and compliance with ISO/IEC 17025
responds to customer inquiries and provides professional advice
hires personnel
orientates new personnel
determines technical training needs of personnel
conducts employee performance reviews
schedules vacation and coverage
ensures that all health and safety regulations are followed
ensures that all Human Rights Legislation are complied with
oversees quality, standard pricing, customized quotations, and invoicing for tests
performed
prioritizes workload
facilitates operational concerns in their area
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ensures accurate and consistent testing procedures through the validation of all
current procedures and by developing, validating and implementing new procedures
coordinates purchasing requests
ensures that the operational needs are within budget and advising management of any
discrepancies

Analyst
maintains records of all quality activities as documented in SOPs and test methods
handles samples and performing analyses according to SOPs and test methods
writes SOPs and test methods
signs reports when designated with signing authority
maintains and calibrates equipment
reports deficiencies or malfunction to the supervisor
identifies and records nonconformities on Corrective Action Requests
identifies and recording potential nonconformities on Preventive Action Requests
corrects nonconformities and potential nonconformities
improves laboratory and/or quality activities on a continuous basis

Customer Representatives and Administrative Personnel


performs work functions and keeps records as per approved SOPs and/or laboratory
policies
writes SOPs
identifies and records nonconformities on Corrective Action Requests
identifies and records potential nonconformities on Preventive Action Requests
corrects nonconformities and potential nonconformities
improves laboratory and/or quality activities on a continuous basis

G) Laboratory Supervision / Technical Managers

Policy:
Adequate supervision is provided in each area of the laboratory for all testing and
calibration personnel, including trainees, by persons familiar with the methods and
procedures. They have overall responsibility for the technical operations and the
provision of resources needed to ensure the required quality of laboratory operations.

Details:
Adequate supervision is ensured through designated supervisors as well as through
documentation such as this Quality Manual, test methods and SOPs. A thorough
orientation and training program is adhered to for all new employees. Ongoing training
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for regular personnel is required. While the technical manager may at times delegate
duties to other personnel, the technical manager is accountable for any nonconforming
activities.

H) Quality Manager

Policy:
The Quality Manager is appointed by the highest level of management. The Quality
Manager, who, irrespective of other duties and responsibilities, has defined responsibility
and authority for ensuring that the management system related to quality is implemented
and followed. The Quality Manager has direct access to the highest level of management
where decisions are taken on laboratory policy or resources.

Details:
This statement notifies all laboratory personnel that Brian McGovern is the Quality
Manager and James Hibbs is the Deputy Quality Manager as authorized below by the
Director. Any change in this position requires the reissue of this section to all holders of
controlled copies of the Quality Manual. The following signature also serves as approval
for this Quality Manual and affirms senior management’s commitment to the policies and
procedures set forth in this manual.

Michael D. Moore
Laboratory Director

I) Managerial Substitutions

Policy:
Deputies for key personnel are appointed to fulfill the key personnel’s duties in their
absence.

Details:
In the absence of the Quality Manager, the Deputy Quality Manager will assume his/her
responsibilities.

In the absence of the Area Supervisor (Technical Manager), the senior analyst for that
department will assume his/her responsibilities.
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Management is responsible for ensuring that current and/or increased workload


requirements are met. This includes making adjustments as a result of employee absence.
Only fully trained employees are utilized to fulfill the duties of personnel who are absent.
If sufficient human resources are not available, management will identify the best
possible solution to meet operational requirements.

J) Awareness

Policy:
Management ensures that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the objectives of the
management system.

Details:
Supervisors review the details of each employee’s job description with the appropriate
employee and how the overall Quality Policy Statement (Section 4.2.2) relates to their
activities to achieve the objectives of the management system.

4.1.6 Communication Processes


Policy and Details:
Top management ensures that appropriate communication processes are established
within the laboratory and that communication takes place regarding the effectiveness of
the management system.

Revision History
Revision 1 - Procedures were added to section 4.1.5.c. to reflect the policies in place to
protect confidential and proprietary client information.

James Hibbs was named as the Deputy Quality Manager.

Revision 2 - Managerial Substitutions have been clarified.

Revision 3 - Customer Confidentiality section was updated.


Organizational Structure section was updated.

Revision 4 - Responsibility and Authority section was updated.


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4.2 Management System

The Ten Second Tutorial

This section tells you that our Management System (or Quality
Management System) is based on:

1. A well-defined quality policy statement


2. Say what you do through documentation
3. Do what you say following your documentation
4. Record what you did

Key Words

Establish, Implement, and Maintain


Policies, Systems, Processes, Programs, Procedures, Instructions
Communicate, Understand
Quality Policy Statement
Quality Manual
SOP
Test Method

Cross-references
ISO 17025:2005 Section 4.2

ISO 9001:2000 Section 4.1, 4.2.1, 4.2.2, 5.1, 5.3, 5.4.1, 5.4.2,
5.5.1, 5.5.2, 6.2.1, 7.1
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4.2.1 Policies and Procedures


Policy:
The Quality Management System is established, implemented, and maintained by
management. It is applicable to all the fields of testing and activities in which the
laboratory is involved and undertakes. All policies, systems, programs, procedures and
instructions are documented to the extent necessary to enable the laboratory to assure the
quality of results generated. These documents are communicated to, understood by,
available to, and implemented by the appropriate personnel.

Details:
The purpose of our Quality Management System is to ensure that all services and
products satisfy the customer’s requirements and have been designed, manufactured, and
delivered under controlled conditions.

The effectiveness of the Quality Management System is assessed in several ways:

by a program of planned internal audits, covering all aspects of the operation of the
quality management system
by regular management reviews of the suitability and effectiveness of the quality
management system
by analysis of potential and actual problems as shown by customer complaints and
supplier and subcontractor assessments
by other methods approved from time to time by the Quality Manager and Director

This Quality Manual and associated documents (including procedures) and records serves
as the quality plan for the laboratory. Other documents and records include:

standard operating procedures


quality control plans in test methods
organizational charts
proposals
project management schemes

4.2.2 Quality Policy Statement


Policy:
The policies and objectives for laboratory operations are documented in this Quality
Manual. The overall objectives are set out in the Quality Policy Statement and reviewed
during management review. The Quality Policy Statement is issued under the authority of
the Director on the effective date.
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Quality Policy Statement:


To ensure accurate and timely analytical services, and to continuously meet or exceed the
stated, or implied, expectations of our customers through day-to-day interactions.
Analytical Laboratories, Inc. is committed to providing the very best in laboratory testing
services to our clients to help them meet their regulatory needs. ALI will adhere to
published procedures required by regulatory agencies while utilizing documented
standard operating procedures (S.O.P.) created internally. The principles and practices of
this policy apply to each employee with ALI.

Effective Date: July 18, 2007

a) Management commitment to good professional practice and quality of services


provided to the customer: tests and calibrations are always carried out in accordance with
stated standardized methods and customers’ requirements. Requests to perform tests that
may jeopardize an objective result or have a low validity are rejected.

b) Standards of service include:


Customer Satisfaction
Precision & Accuracy
Accountability & Traceability
Excellence in the workplace is promoted by providing all employees with the knowledge,
training, and tools necessary to allow for the completion of accurate and timely work.

c) Purpose of management system related to quality: to manage our business by meeting


the needs of our customers.

d) Personnel: familiarize themselves with quality documentation and implement the


policies and procedures in their work.

e) Management is committed to complying with ISO 17025 and ISO 9001 international
standards and to continually improve the effectiveness of the management system: the
objective of this Quality Manual is to document the compliant policies and associated
procedures that are integrated into our daily activities. Continual improvements are
established, implemented, and locked into the management system.

Additional objectives include:

to establish the level of the laboratory’s performance


to make test method changes to improve performance
to participate in proficiency testing or quality evaluation programs with peer
laboratories
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to ensure that all personnel are trained to a level of familiarity with the quality
management system appropriate to the individual’s degree of responsibility
to improve and validate laboratory methodologies by participation in method
validation collaborative tests
to establish and report on quality savings

4.2.3 Commitment to the Management System


Policy:
Top management is committed to the development and implementation of the
management system and continually improving its effectiveness.

Details:
The results of the management system are regularly reviewed during management review
(see Section 4.15) and continual improvements are made as outlined in Section 4.10 –
Improvements.

4.2.4 Communication of Requirements


Policy:
Top management communicates to the organization the importance of meeting customer
requirements as well as statutory and regulatory requirements.

Details:
In general, the underlying message in all oral and written management communications
involves meeting the aforementioned requirements. Meeting customer requirements
ensures that ongoing business relationships secure the contracts that keep everyone
employed. Meeting statutory and regulatory requirements ensures that laboratory
operations will not be disrupted and the organization can continue to meet customer
needs.

4.2.5 Quality Manual


Policy:
This Quality Manual outlines the structure of the documentation used in the quality
management system. This Quality Manual makes reference to supporting procedures
including technical procedures and is maintained up to date.

Details:
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This quality management system is structured in three tiers of documentation. The tiers
are as follows:
I. Quality Manual
II. Standard Operating Procedures and Test Methods
III. Records

For most customers, this Quality Manual and the associated documents form a general
Quality Plan. If necessary, specific Quality Plans will be prepared on a ‘per-customer’
basis. These Quality Plans will modify the general requirements stated in the Manual and
associated documents.

All of the above documents are controlled documents.

The following records and directive documents are referenced in the Quality Manual, but
maintained separately:
organizational chart (section 4.1.5.E)
copies of the Quality Policy Statement posted in the laboratory (section 4.2.2)
identification of resources and management review (section 4.15.1)
job descriptions (section 5.2.4)
statistical techniques (section 5.9)
test reports (section 4.13.2 and 5.10)
identification of the laboratory’s approved signatures (section 5.10.2)
laboratory’s scope of tests (section 4.1.3)
equipment inventory and records (sections 5.5.4 and 5.5.5)
calibration status indicators (section 5.5.8)
reference standards inventory (section 5.6.3)
verification records (section 5.9)
quality control plan / criteria for workmanship (section 5.4.1)
corrective action records (section 4.11)
preventive action records (section 4.12)
customer complaint records (section 4.8.1)
audit schedule and records (section 4.14.3)
procurement and subcontracting records (sections 4.6 and 4.5.4)
training records (section 5.2.5)
master list of documentation (section 4.3.2)
confidentiality agreements (section 4.1.5 C)
contract review (section 4.4.2)
validation of test methods (section 5.4.5)
facility floor plan (section 5.3.1)

4.2.6 Technical Management and the Quality Manager


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The roles and responsibilities for technical management and the Quality Manager are
outlined in section 4.1.5 (F) of this manual.

Technical management ensures that section 5 of this manual is implemented and


maintained. The Quality Manager ensures that section 4 of this manual is implemented
and maintained.

4.2.7 Maintenance
Policy and Details:
Top management ensures that the integrity of the management system is maintained
when changes to the management system are planned and implemented.

Revision History
Revision 0
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4.3 Document Control

The Ten Second Tutorial


This section tells you that Document Control involves:

1. Writing good procedures


2. Getting them to the users
3. Keeping procedures good

Key Words
Controlled Document
Master List
Unique Identification
Revise
Revision Number
Effective Date
Review and Approval
Obsolete
Archive
Hand-written changes

Cross-references
ISO 17025:2005 Section 4.3

ISO 9001:2000 Section 4.2.1, 4.2.3, 4.2.4


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4.3.1 Policies and Procedures


Policy:
The SOP# QSP 4-3-1 is used to control all quality management system documents
(internally generated and from external sources). These include documents of external
origin, such as regulations, standards, other normative documents, test and/or calibration
methods, as well as drawings, specifications, instructions, and manuals.

Details:
Document means any information or instructions including policy statements,
procedures, specifications, calibration tables, charts, text books, posters, notices,
memoranda, software, drawings, and plans. These may be in various media, whether hard
copy or electronic and they may be digital, analog, photographic or written.

The documents to be controlled include:


Quality Manual
Standard Operating Procedures and test methods
Forms
Standards

The control of data related to testing and calibration is covered in section 5.4.7. The
control of records is covered in section 4.13.

4.3.2 Document Approval and Issue


4.3.2.1 Review / Approval / Master List

Policy and Details:


All documents issued to personnel in the laboratory as part of the quality management
system are reviewed and approved for use by authorized personnel prior to issue (i.e.,
reviewed by personnel knowledgeable in the documented activity and then approved by
management). A master list identifying the current revision status and distribution of
documents in the quality management system is readily available in order to preclude the
use of invalid and/or obsolete documents (see SOP# QSP 4-3-1). A revision history of
documents is also maintained. Documents are formally reviewed on a biennial basis to
ensure their continuing suitability.

4.3.2.2 Availability and Obsolete Documents

Policy and Details:


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The master list shows the current status of all controlled documents. The master list
document is organized with the following information:
Title
Revision # / date of last revision
Date of issue / last review
Status (current, obsolete, dormant, or assigned)
Distribution list (copy number)

Controlled documents are approved before issue.

The SOP# QSP 4-3-1 for document control ensures that:


authorized editions of appropriate documents are available at all locations where
operations essential to the effective functioning of the laboratory are performed
documents are periodically reviewed and where necessary revised to ensure
continuing suitability and compliance with applicable requirements
invalid or obsolete documents are promptly removed from all points of issue or use to
assure against unintended use
obsolete documents retained for either legal or knowledge preservation purposes are
suitably marked (i.e., stamped "OBSOLETE" and dated)

4.3.2.3 Identification

Policy and Details:


All quality management system documentation is identified by:

date of issue and/or revision number


page numbering
total number of pages (e.g., page 5 of 5)
issuing authority (i.e., approval signature)

4.3.3 Document Changes


4.3.3.1 Review / Approval

Policy:
Changes to documents are reviewed and approved by the same function (i.e., personnel or
position) that performed the original review unless specifically designated otherwise. The
designated personnel have access to pertinent background information upon which to
base their review and approval.

Details:
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Developments in policies and procedures require documents to be changed from time to


time. Changes to documents receive the same level of review and approval as the
originals.

The Quality Manual is reviewed annually by the Quality Manager. Records are kept of
this review.

Test methods and SOPs are reviewed on a biennial basis. Procedures for this are outlined
in SOP# QSP 4-3-1.

Obsolete documents are withdrawn, but are retained for archive purposes and clearly
labeled as obsolete.

4.3.3.2 Identification of Changes

Policy:
The nature of document changes is identified in the document.

Details:
As outlined in SOP# QSP 4-3-1.

Revision history is recorded at the end of the document.

4.3.3.3 Amendments by Hand

Policy and Details:


Hand-written amendments to documents are not permitted

4.3.3.4 Computerized Documents

Policy and Details:


The SOP# QSP 4-3-1 details how changes in documents maintained in computerized
systems are made and controlled.

Revision History
Revision 1 03-05-08 Section 4.3.3.2 updated to reflect current policies.
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Section 4.4 – Review of Requests, Tenders, and Contracts
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4.4 Review of Requests, Tenders, and Contracts

The Ten Second Tutorial


This section tells you that you must:

1. Clearly understand customer requirements

Key Words
Requirements
Subcontractor
Request
Tender
Contract
Review

Cross-references
ISO 17025:2005 Section 4.4

ISO 9001:2000 Section 5.2, 6.1, 7.2.1, 7.2.2, 7.2.3


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4.4.1 Policies and Procedures

Policy:
The SOP# QSP 4-4-1 is used to review requests, tenders, or contracts. This procedure
ensures that:
a) the customer requirements including the methods to be used are adequately defined,
documented and understood (see section 5.4.2)
b) the laboratory has the capability and resources to meet the requirements
c) the appropriate test method is selected and capable of meeting the customer’s
requirements (see section 5.4.2)

Any differences between the request or tender and the contract are resolved before any
work commences. Each contract must be acceptable by both the laboratory and the
customer.

Details:
The request, tender and contract review is conducted in a practical and efficient manner,
and the effect of financial, legal, and time schedule aspects are taken into account.

The review of capability establishes that the laboratory possesses the necessary physical,
personnel, and information resources, and that the laboratory’s personnel have the skills
and expertise necessary for the performance of the tests in question. The review may also
encompass results of earlier participation in inter-laboratory comparisons or proficiency
testing and/or the running of trial test using samples or items of known value in order to
determine uncertainties of measurement, limits of detection, and confidence limits.

The contract review ensures that each customer’s requirements are adequately defined
and documented before the service or product is ordered or dispatched. This should
ensure that any order, once accepted, can be completed without delay, and that the
customer’s requirements including delivery date, technical specification, and cost can be
met.

If the contract review highlights any ambiguities or uncertainties then the customer will
be contacted and the problem resolved before the order is accepted.

The SOP# QSP 4-4-1 also describes the activities that take place should there be a
subsequent amendment to a customer’s order.
Typical types of contracts include:

approved service quotations


confidentiality agreements
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non-disclosure agreements
sample submission requests
memorandum of agreement
memorandum of understanding
research proposals and contracts
verbal orders (oral agreements)
activity plans

4.4.2 Records of Review


Policy:
Records of request, tender and contract review, including significant changes, are
maintained. Records of pertinent discussions with a customer relating to the customer’s
requirements or the work during the period of execution of the contract are also
maintained.

Details:
For review of routine and other simple tasks, the date and the identification (e.g., initials)
of the person in the laboratory responsible for carrying out the contracted work are
considered adequate. For repetitive routine tasks, the review need be made only at the
initial inquiry stage or on grant of the contract for on-going routine work performed
under a general agreement with the customer, provided that the customer’s requirements
remain unchanged. For new, complex or advanced testing tasks, a more comprehensive
record is maintained.

4.4.3 Review of Subcontracted Work


Policy:
Request, tender, and contract review also includes work that is subcontracted by the
laboratory.

Details:
Subcontractor laboratories are reviewed as described in section 4.5.

4.4.4 Notification of Customer


Policy and Details:
Customers are informed of deviations from the contract. This is typically communicated
to the customer prior to the performing the deviation.
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4.4.5 Contract Amendment


Policy and Details:
If a contract needs to be amended after the work has commenced, the same contract
review process is repeated and any amendments are communicated to all affected
personnel.

Revision History
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Section 4.5 – Subcontracting of Tests and Calibrations
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4.5 Subcontracting of Tests and Calibrations

The Ten Second Tutorial


This section tells you that we must:

1. Know what tests and calibrations need to be done by


another laboratory
2. Check out the other laboratories

Key Words
Competence
Register of Subcontractors
Assessment

Cross-references
ISO 17025:2005 Section 4.5

ISO 9001:2000 Section 7.2.3, 7.4.1, 7.4.3, 8.2.4


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4.5.1 Subcontractor Competence


Policy:
Work that must be subcontracted due to:
unforeseen circumstances
workload
large contracts
contracts requiring some extra technical expertise
testing not currently being done by A.L.I.

is subcontracted to a technically competent laboratory.

Details:
The subcontracted laboratory demonstrates technical competence by possession or receipt
of one or more of the following:
recognized technical accreditation
registration under the ISO 9001 standard
satisfactory performance of appropriate quality control check samples, certified
reference material, in-house reference material or replicate analysis
audit of the subcontractor’s quality management system by our auditors

It is the responsibility of the Quality Manager to assess and approve the competence level
of subcontractor laboratories.

4.5.2 Customer Approval


Policy:
Customers are advised of work (or any portion thereof) that is being subcontracted to
another laboratory and their approval is obtained (preferably in writing).

Details:
Customers are advised of subcontracted work through fee schedules or any type of
contract listed in section 4.4.1.

4.5.3 Assurance of Subcontractor Competence


Policy:
The laboratory is responsible to the customer for the subcontractor’s work. Technical
competence of subcontractor laboratories is demonstrated through various records.
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Note – there may be circumstances where the customer specifies which


subcontractor is to be used. In such cases we may not be able to demonstrate the
competence of the subcontractor and therefore are not responsible for the results.

Details:
Records of subcontractor competence include, but are not limited to, the following:
accreditation certificates or documentation
registration certificates
check sample results
audit results
approval by the Quality Manager

4.5.4 Subcontractor Register


Policy:
A register of all subcontractors performing tests and calibrations is maintained.

Details:
The approved register of subcontractors and all assessment records are maintained by the
Quality Manager.

Revision History
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Section 4.6 – Purchasing Services and Supplies
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4.6 Purchasing Services and Supplies

The Ten Second Tutorial


This section tells you that we must:

1. Know what we want


2. Check out our suppliers

Key Words
Selection
Verify
Specifications
History

Cross-references
ISO 17025:2005 Section 4.6

ISO 9001:2000 Section 6.3.1, 7.4, 7.5.5, 8.2.4


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4.6.1 Policies and Procedures


Policy:
The SOP# QSP 4-6-1 is used to select and purchase services and supplies. The SOP#
QSP 4-6-1 is used for procurement, reception, and storage of supplies.

Details:
Consumable materials are stored according to the appropriate test method, SOP, or work
instruction.

4.6.2 Specifications
Policy:
Only services and supplies of the required quality are used. These quality requirements
are detailed in laboratory SOPs under the “Equipment and Supplies” and “Reagents and
Standards” sections and will identify the appropriate minimum specifications when
necessary.

Details:
Packing slips are checked against package content labels and matched with the Purchase
Order or invoice if accepted. Once accepted, the invoice is dated and initialed as evidence
of compliance. Certificates of analysis (COA) are maintained on file after the COA is
checked to ensure the received item meets minimum specifications.

Chemicals are purchased with manufacturer’s certificates where possible. Uncertified


chemicals are purchased from ISO 9000 registered companies. Whatever the source, the
laboratory verifies the quality of the standards by comparing the new batch of standards
to the old. Due regard is paid to the manufacturer’s recommendations on storage and
shelf life.

Reagents are generally purchased from manufacturers who have a quality management
system based on ISO 9000. The grade of any reagent used (including water) is stated in
the method together with guidance on any particular precautions to be observed in its
preparation or use.

Where no independent assurance of the quality of procured goods or services is available


or the supplier’s evidence is insufficient the laboratory ensures that purchased goods and
services comply with specified requirements. Where possible and practical the laboratory
ensures that goods are inspected, calibrated, or are otherwise in compliance with any
standard specification relevant to the calibrations or tests concerned.
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4.6.3 Purchasing Documents


Policy:
Purchasing requests are recorded on a Supply Request form and contain data describing
the product ordered. The Supply Request form is reviewed and approved for technical
content prior to release.

Details:
The description may include type, class, grade, precise identification, specifications,
drawings, inspection instructions, other technical data including approval of test results,
quality required and quality management system standard under which they were
produced.

The completion of the Supply Request form is the responsibility of the area supervisor.

4.6.4 Approved Suppliers


Policy:
Suppliers of critical services are evaluated and approved before use. An approved
supplier list is maintained.

Details:
Audits or tender evaluation is conducted to qualify suppliers of critical services prior to
use. The criteria for evaluation may include, but is not limited to the following:

references
accreditation
formal recognition

The records are maintained by the Area Supervisor.

Revision History
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Section 4.7 – Service to the Customer
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4.7 Service to the Customer

The Ten Second Tutorial


This section tells you that we must:

1. Facilitate clarification of the customer’s request


2. Give customer access to relevant testing area
3. Maintain customer contact
4. Inform customer of delays or deviations
5. Utilize customer surveys

Key Words
Clarification
Deviations
Delays
Customer Satisfaction Survey

Cross-references
ISO 17025:2005 Section 4.7

ISO 9001:2000 Section 6.1, 7.2.1, 7.2.3, 7.4.3, 7.5.1


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4.7.1 Service
Policy:
Customer requests are clarified for the customers or their representatives. Furthermore
the customer or their representative will be afforded the right to monitor the performance
of the laboratory in relation to the work performed, provided that the laboratory ensures
confidentiality to other customers.

Details and Procedures:


Service to the customer includes:

Affording the customer or the customer’s representative reasonable access to relevant


areas of the laboratory for the witnessing of work performed for the customer; it is
understood that such access should not conflict with rules of confidentiality of work
for other customers or with safety.

Preparing, packaging, and dispatching of test items needed by the customer for
verification purposes.

Maintaining of open contacts. The customer values advice and guidance in technical
matters, and opinions and interpretations based on results. Contact with the customer,
especially in large assignments, should be maintained throughout the work. The
laboratory should inform the customer of any delays or major deviations in the
performance of the tests.

4.7.2 Feedback
Policy and Details:
The laboratory seeks feedback from the customer. Positive and negative feedback can be
obtained passively through ongoing communications with the customer (e.g., review of
test reports with customers) or actively through customer satisfaction surveys. The
feedback is used to improve the quality management system, testing activities, and
customer service.

Revision History
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Section 4.8 – Complaints
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4.8 Complaints

The Ten Second Tutorial


This section tells you that you must:

1. Maintain records of Complaints


2. Maintain records of Corrective Action

Key Words
Resolving
Investigation
Corrective Action
Follow-up Verification

Cross-references
ISO 17025:2005 Section 4.8

ISO 9001:2000 Section 7.2.3


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4.8.1 Policies and Procedures


Policy:
The SOP# QSP 4-8-1 is used for resolving complaints received from customers or other
parties. Records are maintained of all complaints and follow-up.

Details:
Records of complaints include the following information:

details of the complaint


investigation
corrective action
follow-up verification

See also section 4.11.

All personnel are responsible for recording and responding to complaints.

Revision History
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Section 4.9 – Control of Nonconforming Work
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4.9 Control of Nonconforming Testing and Calibration Work

The Ten Second Tutorial


This section tells you that you must:

1. Stop testing when nonconforming work is identified


2. Determine what is causing nonconforming work

Key Words
Nonconforming
Root Cause

Cross-references
ISO 17025:2005 Section 4.9

ISO 9001:2000 Section 5.5.1, 7.4.3, 7.5.1, 8.2.4, 8.3, 8.5.3


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4.9.1 Procedures to Control Nonconforming Work


Policy:
The SOP# QSP 4-9-1 is used to control any aspect of testing and/or calibration work, or
the results of this work, when they do not conform with the test methods or the agreed
requirements of the customer.

Details:
The procedure ensures that:
Responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting of work and withholding of test reports as
necessary) are defined and taken into consideration when nonconforming work is
identified
an evaluation of the significance of the nonconforming work is made
correction is taken immediately, together with any decision about the acceptability of
the nonconforming work
where necessary, the customer is notified and the work is recalled
the responsibility for authorizing the resumption of work is defined

Identification of nonconforming work or problems with the quality management system


or with testing activities can occur at various locations within the quality management
system and technical operations such as:
customer complaints
quality control
instrument calibration
checking of consumable materials
staff observations or supervision
test report checking
management reviews
internal or external audits

4.9.2 Root Cause Analysis


Policy:
Where evaluation indicates that nonconforming work could recur or that there is doubt
about the compliance of the laboratory’s operations with its own policies and procedures,
the corrective action procedures given in 4.11 are followed to identify the root cause(s) of
the problem and to eliminate this (these) cause(s).

Details:
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The SOP# QSP 4-11-1 outlines the recording of the root cause analysis for investigating
nonconforming work.

Situations warranting corrective action investigation include:


failure to comply with test method including all applicable procedures necessary to
ensure the integrity and representative nature of the sample
presentation of uncertain knowledge as to compliance with test methods including all
applicable procedures necessary to ensure the integrity and representative nature of
the sample
failure or suspected failure in method performance as demonstrated by results
provided by quality control samples
lack of relevant evidence provided by quality audit, proficiency testing, or customer
feedback
lack of relevant evidence provided by data validation
neglect to check the inherent property of the sample that compromises the testing

Revision History
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Section 4.10 – Improvements
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4.10 Improvements

The Ten Second Tutorial


This section tells you that you must:

1. Review procedures for improvements


2. Continually implement improvements

Key Words
Continually
Effectiveness
Analysis of data

Cross-references
ISO 17025:2005 Section 4.10

ISO 9001:2000 Section 6.1, 8.1, 8.2.1, 8.4, 8.5.1


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4.10.1 Policies and Procedures


Policy:
The laboratory continually improves the effectiveness of its management system through
the use of the quality policy, quality objectives, audit results, analysis of data, corrective
actions, and management review.

Details:
The laboratory has implemented a continual improvement philosophy within the
management system. Every employee in the laboratory is encouraged to suggest new
ideas for improving services, processes, systems, productivity, and the working
environment.

Opportunities for improvement of operations and processes are identified by managers on


a continual basis from ongoing feedback on operations and through management reviews.
Opportunities for improvement of services are identified by anyone within the
organization.

Inputs for improvement opportunities are obtained from the following sources:
customer satisfaction surveys and any other customer feedback
market research and analysis
employees, suppliers, and other interested parties
internal and external audits of the management system
records of service nonconformities
data from process and service characteristics and their trends

Opportunities for improvement may also be identified on a special project basis. The
following are listed only as examples:
improving usefulness of bench space
reducing excessive inspection/testing
reducing excessive handling and storage
reducing test/calibration failures

Opportunities for improvement from daily feedback on operational performance (i.e.,


internal audits, customer feedback, and test/calibration failures) are evaluated by the
Supervisors (Technical Managers) or Quality Manager. Typically, they are implemented
through the corrective and preventive action system.

Opportunities for improvement from analysis of longer-term data and trends are
evaluated and implemented through the management review process. They are prioritized
with respect to their relevance for achieving quality objectives. When opportunities for
improvement are no longer supported by the current policy and objectives, management
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will establish new quality objectives, and possibly change the policy. The process for this
evaluation is described in Section 4.15. Longer-term improvement projects are initiated
through the management review process, as well as the corrective and preventive action
system.

Service improvement opportunities are evaluated by management. They are implemented


through the supervisor of the laboratory who ensures that the improvements are validated
as outlined in Section 5.4 of this manual and appropriate level of quality control is
performed on an ongoing basis.

Revision History
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Section 4.11 – Corrective Action
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4.11 Corrective Action

The Ten Second Tutorial


This section tells you that you must:

1. Identify problems
2. Determine why the problem occurred
3. Fix the cause of the problem
4. Verify that your changes worked

Key Words
CAR
Root Cause
Monitor
Audit
Nonconforming work

Cross-references
ISO 17025:2005 Section 4.11
ISO 9001:2000 Section 5.5.1, 5.5.2, 8.1, 8.2.2, 8.2.3, 8.4, 8.5.2,
8.5.3
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4.11.1 General
Policy:
The SOP# QSP 4-11-1 is utilized for implementing corrective action when
nonconforming work or departures from policies and procedures in the quality
management system or technical operations have been identified. The procedure requires
that appropriate authority be designated for the implementation of corrective actions. The
procedure includes cause analysis, selection and implementation of corrective action, and
monitoring of actions.

Details:
Problems with the quality management system or technical operations of the laboratory
may be identified through a variety of activities, such as control of nonconforming work,
internal or external audits, management reviews, feed-back from customers, or staff
observations.

Corrective action investigations are documented and required changes to operational


procedures are implemented. The corrective action request (CAR), investigation and
resolution are recorded on a CAR form.

4.11.2 Cause Analysis


Policy:
Corrective action always begins with an investigation to determine root cause(s) of the
problem (see SOP# QSP 4-11-1).

Details:
Potential causes of the problem could include customer requirements, the samples,
sample specifications, methods and procedures, personnel skills and training, consumable
materials, or equipment and its calibration.

4.11.3 Selection and Implementation of Corrective Actions


Policy and Details:
After determining the cause(s) of the problem, potential corrective actions are identified.
The most likely action(s) (this includes practical and/or reasonable) are selected and
implemented to eliminate the problem and to prevent recurrence. It should be noted that
any corrective actions taken to eliminate the cause(s) of nonconformities or other
departures are to a degree appropriate to address the magnitude of the problem and
commensurate with the risks encountered (Note – in plain language, this means
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determine whether the benefit outweighs the cost). Controls are applied to prevent
recurrence. The laboratory documents and implements the required changes resulting
from corrective action investigations.

4.11.4 Monitoring of Corrective Action


Policy:
After implementing the corrective action(s), the laboratory monitors the results to ensure
that the actions taken have been effective in overcoming the problems originally
identified.

Details:
Monitoring is assigned to an appropriate individual such as the originator of the CAR or
the originator’s manager. Changes resulting from corrective action are documented.

4.11.5 Additional Audits


Policy:
Where the identification of nonconformities or departures casts doubts on compliance of
policies, procedures, regulations, international quality standards, the appropriate areas of
activity are promptly audited in accordance with section 4.14.

Details:
Special audits follow the implementation of corrective actions to confirm their
effectiveness. A special audit is only necessary when a serious issue or risk to the
business is identified. Special audits are carried out (whenever resources permit) by
trained and qualified personnel who are independent of the activity to be audited. See
section 4.14 for more details.

Revision History
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Section 4.12 – Preventive Action
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4.12 Preventive Action

The Ten Second Tutorial


This section tells you that you must:

1. Identify potential problems


2. Determine why the problem could occur
3. Fix the cause of the potential problem
4. Verify that your changes worked

Key Words
PAR
Potential Nonconformity
Action Plan

Cross-references
ISO 17025:2005 Section 4.12

ISO 9001:2000 Section 4.2.4, 6.3.1, 8.4, 8.5.1, 8.5.2, 8.5.3


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4.12.1 Preventive Action Identification


Policy:
Opportunities for needed improvement and potential sources of nonconformities, either
technical or with the quality management system shall be identified. If action is required,
action plans are developed, implemented and monitored, to reduce the likelihood of
occurrence of such nonconformities and to take advantage of the improvement
opportunities.

Details:

Records of preventive action include the following information:

details of potential nonconformities


investigation
preventive action
follow-up verification

These records are maintained in the Corrective Action Request / Preventive Action
Request (PAR) form/binder.

4.12.2 Preventive Action Plans


Policy:
The preventive action procedure includes the initiation of such actions and application of
controls to ensure that they are effective.

Details:
Preventive action may result from the review of operational procedures and analysis of
data. Analysis of data includes trend analysis, analysis of proficiency testing results, and
risk analysis.

The SOP# QSP 4-12-1 is utilized to implement opportunities for needed improvement
and prevent potential sources of nonconformities.

Revision History
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Section 4.13 – Control of Records
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4.13 Control of Records

The Ten Second Tutorial


This section tells you that you must:

1. Identify the records to be kept


2. Keep identified records in a useful state
3. Destroy records when they are no longer needed

Key Words
Collection
Indexing
Access
Storage
Maintenance
Disposition
Legible
Traceable
Retrievable
Secure

Cross-references
ISO 17025:2005 Section 4.13

ISO 9001:2000 Section 4.2.4, 6.3, 6.4, 7.1, 7.5.1, 7.5.2, 7.5.3, 8.1,
8.2.2, 8.2.3, 8.2.4
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4.13.1 General
4.13.1.1 Procedures

Policy:
The SOP# QSP 4-13-1 is used to identify, collect, index, access, file, store, maintain,
protect, backup, and dispose of quality and technical records. Quality records include
reports from internal audits and management reviews as well as corrective and preventive
action records.

Details:
Records are available to demonstrate conformance to requirements and effective
operation of the Quality Management System. Quality records from suppliers are also
controlled.

All records, including test reports, are safely stored and held secure in locked areas, and
in confidence to the customer. Records are maintained in the designated archival area for
10 years.

The master list of records is organized with the following information:


Record No. / Form No.
Record Name
Filing Method (loose forms filed monthly, quarterly, semi-annual, annual or
electronic)
Active Files (files referred to within the work area) / Retention Period / Location
Inactive Files (files referred to but not often and kept in storage) / Retention Period /
Location
Persons / Positions Responsible / Users

The dating format for records is [YY/MM/DD].

4.13.1.2 Record Integrity

Policy:
All records are to be legible and shall be retained in such a way that they are readily
retrievable in facilities that provide a suitable environment to prevent damage or
deterioration and to prevent loss.

Details:
The retention times for records are generally set at 10 years. Records may be in the form
of any type of media, such as hard copy or electronic media. Exceptions to this are
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retention times for work area-specific records are determined by the laboratory and stated
in their quality management system documents. An example of work area-specific
retention times, for compliance samples that are tested under the jurisdiction of DEQ and
the EPA, is as follows:
Chemistry Chemical Analyses 10 years retention time
Lead & Copper Analyses 12 years retention time
Microbiology Microbiological Analyses 5 years retention time
Radiochemistry Radionuclide Analyses 10 years retention time

4.13.1.3 Record Security

Policy:
All records are held secure and in confidence.

Details:
Access to records is secured through locked rooms and filing cabinets.

4.13.1.4 Record Backup

Policy:
The SOP# QSP 4-13-1 is followed to protect and backup data/records held on computers
at all times and to prevent unauthorized access to or amendment of data/records on
computers.

Details:
Data is password protected.

Backups ensure integrity and availability of data / information in the event of a system /
power failure.

4.13.2 Technical Records


4.13.2.1 Record Information

Policy:
Original observations, calculations, derived data and sufficient information to establish an
audit trail, calibration records, personnel records and a copy of each test report issued are
retained for 10 years.
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The records for each test or calibration shall contain sufficient information to facilitate, if
possible, identification of factors affecting the test uncertainty and to enable the test or
calibration to be repeated under conditions as close as possible to the original. The
records include the identity of personnel responsible for sampling, performing of each
test and/or calibration and checking of results.

Details:
Technical records are accumulations of data (see 5.4.7) and information that result from
carrying out tests and/or calibrations and which indicate whether specified quality or
process parameters are achieved. They may include forms, contracts, work sheets, work
books, note books, instrument printouts, magnetic media, check sheets, work notes,
control graphs, test reports, calibration certificates, customer’s notes, papers and
feedback, and test reports to customers.

The records for each test contain sufficient information to permit its repetition. Records
include:
date and time of sampling
date and time of sample receipt
sample handling, storage, and disposal
identification of personnel
analyst proficiency
equipment identification and performance
calibration records
media performance, where appropriate
test organism batch # or lot #, where appropriate
results
reports (mailed, faxed)
review

Note – the above records may be stored in separate locations. They are cross-referenced
for easy retrieval.

4.13.2.2 Recording

Policy:
Observations, data, and calculations are clearly and permanently recorded and
identifiable to the specific job at the time they are made.

Details:
Handwritten records must be legible and made with indelible ink immediately after an
observation, after data is collected and/or after calculations are made.
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4.13.2.3 Corrections to Records

Policy:
Changes to test data are made so as not to obscure or delete the previous data entry.

Details:
Mistakes are crossed out and the correct value entered alongside. Mistakes are not erased,
made illegible, or deleted. All alterations to records are signed or initialed by the person
making the correction. In the case of computer-collected data, similar measures are taken
to avoid loss or change of original data.

Revision History
Revision 1 - Details were changed to reflect the length of time that records are retained
from 7 to 10 years.

Details were added to section 4.13.1.2 to reflect retention times specific to


compliance samples tested under the jurisdiction of DEQ and the EPA.
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Section 4.14 – Internal Audits
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4.14 Internal Audits

The Ten Second Tutorial


This section tells you that:

1. Trained internal auditors examine your internal operations


for quality
2. Auditors report the results to those in charge
3. You must correct any areas that need fixing

Key Words
Schedule
Elements
Independent
Nonconformity
CAR

Cross-references
ISO 17025:2005 Section 4.14

ISO 9001:2000 Section 8.1, 8.2.2, 8.2.3


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4.14.1 Internal Audit Program


Policy:
The internal audit program involves periodic audits conducted according to a
predetermined schedule for each year. This program is defined on an annual basis and
conducted as outlined in this section with further details found in SOP# QSP 4-14-1. All
elements of this Quality Manual will be audited each year and all relevant laboratory
records are available to personnel conducting the audit. These audits are performed to
verify operations continue to comply with the requirements of this Quality Manual and
are effective.

Details:
The Quality Manual, test procedures, and laboratory results are verified for compliance.
It is the responsibility of the Quality Manager to plan and organize audits as required by
the schedule and requested by management. Audits are carried out by trained and
qualified personnel who are (wherever resources permit) independent of the activity to be
audited. Personnel are not to audit their own activities except when it can be
demonstrated that an effective audit will be carried out (see also 4.11.5). Audits are
performed through the aid of a checklist prepared in advance to minimize the possibility
of overlooking any details during the audit.

Generally, the types of audits include:


quality management system
processes and procedures
products, services, and reports

4.14.2 Corrective Action


Policy:
When audit findings cast doubt on the effectiveness of the operations or on the
correctness or validity of test or calibration results, timely corrective action is taken and
customers are notified if investigations show that laboratory results may have been
affected.

Details:
Nonconformities that can be resolved easily are to be corrected immediately, ideally
during the audit. Records are made on the audit checklist. Nonconformities that require a
more involved resolution are recorded on a CAR and resolved as described in section
4.11.
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Corrective actions and customer modifications must be kept on record for each audit
deviation that casts doubt as described in this section.

4.14.3 Records and Management


Policy:
Records are made of the activity being audited, the audit findings, and corrective actions
that arise. Management ensures that corrective actions are discharged within an
appropriate and agreed timeline.

Details:
A report is prepared by the auditors and distributed to those audited and/or the area
manager/supervisor within an appropriate and agreed timeline. The audit report may
include the following sections, as appropriate:
audit objective and scope
area or section audited
personnel involved – auditors and auditees
date of audit
reference documents
observations including nonconformities and commendations
opening and closing meetings
recommendations
audit report distribution

The appropriate manager is responsible for ensuring that corrective actions are
sufficiently recorded. Follow-up is performed by the auditor and recorded when
corrective action is complete and deemed effective. The audit records are kept in the
laboratory.

4.14.4 Follow-up Audits


Policy:
Follow-up audits are performed to verify and record the implementation and
effectiveness of the corrective action taken.

Details:
The follow-up audit is performed at a mutually acceptable time between the area
implementing corrective action and the auditor. This time is determined when the CAR is
issued.
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Revision History
Revision 0
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Section 4.15 – Management Reviews
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4.15 Management Reviews

The Ten Second Tutorial


This section tells you that management must:

1. Periodically review technical competence and customer


satisfaction
2. Keep records of reviews
3. Ensure follow-up is executed
4. Measure progress

Key Words
Supervisor Reports
Audit Reports
CAR / PAR
Proficiency Results
Customer Satisfaction Survey
Resources

Cross-references
ISO 17025:2005 Section 4.15

ISO 9001:2000 Section 5.1, 5.4.2, 5.6, 6.2.1, 7.1, 8.5.1


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4.15.1 Review of Quality Management System and Testing


Policy:
Top management periodically (at least annually) and in accordance with a predetermined
schedule and SOP# QSP 4-15-1, conduct a review of the laboratory’s quality
management system and testing and/or calibration activities to ensure their continuing
suitability and effectiveness and to introduce any necessary changes or improvements.

Details:
The review takes account of:
suitability of policies and procedures
reports from managerial and supervisory personnel
the outcome of recent internal audits
corrective and preventive actions
assessments by external bodies
results of inter-laboratory comparisons or proficiency tests
changes in the volume and type of work undertaken
feedback from customers, including complaints and customer satisfaction surveys
recommendations for improvement
other relevant factors, such as quality control activities, resources and personnel
training

A minimum period for conducting a management review is once a year. Results of the
review feed into the laboratory planning system and include goals, objectives and action
plans for the coming year.

A management review can be supplemented by consideration of related subjects at


regular management meetings.

4.15.2 Findings, Actions, and Records


Policy and Details:
Findings from management reviews and the actions that arise are recorded in the minutes
of the meeting. Management will ensure that the actions are discharged within an
appropriate and agreed upon timeline.

Revision History
Revision 0
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Section 5.1 - General
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5.1 General

The Ten Second Tutorial


This section informs you that:

1. Many factors contribute to the correctness and reliability of tests


and/or calibrations
2. The laboratory must account for these factors

Key Words
Correctness
Reliability
Uncertainty

Cross-references
ISO 17025:2005 Section 5.1

ISO 9001:2000 Section 7.1, 7.5.1


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5.1.1 Correctness and Reliability


Policy and Details:
Correctness and reliability of the tests and/or calibrations performed have many
contributing factors including:

¾ human factors (see section 5.2)


¾ accommodation and environmental conditions (see section 5.3)
¾ test and calibration methods and method validation (see section 5.4)
¾ equipment (see section 5.5)
¾ measurement traceability (see section 5.6)
¾ sampling (see section 5.7)
¾ handling of test and calibration items (see section 5.8)

5.1.2 Measurement Uncertainty


Policy:
When developing test and calibration methods and procedures, total measurement
uncertainty must be accounted for in the training and qualification of personnel, and in
the selection and calibration of equipment.

Details:
The extent to which the factors contribute to total measurement uncertainty differs
between (types of) tests and between (types of) calibrations.

See section 5.4.6 for more details.

Revision History
Revision 0
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Section 5.2 - Personnel
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5.2 Personnel

The Ten Second Tutorial


This section tells you that management:

1. Analyzes training needs


2. Provides training to employees for them to do their jobs
3. Qualifies people performing specific tasks

Key Words
Competence
Qualification
Authorize
Training Needs
Job Description
Registry of Skills

Cross-references
ISO 17025:2005 Section 5.2

ISO 9001:2000 Section 5.5.1, 6.2.1, 6.2.2, 7.5.1, 7.5.2


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5.2.1 Competence and Qualification


Policy:
Management ensures the competency of all specific equipment operators, those
performing tests and/or calibrations, those evaluating results and signing test reports.
Appropriate supervision is provided for employees undergoing training. Personnel
performing specific tasks are qualified on the basis of appropriate education, training,
experience and/or demonstrated skills, as required.

In addition, personnel responsible for the opinions and interpretations included in test
reports also have:
¾ relevant knowledge of the technology used for the manufacturing of the items,
materials, products tested, or the way they are used or intended to be used and of the
defects or degradation that may occur during or in service
¾ knowledge of the general requirements expressed in the legislation and standards
¾ an understanding of the significance of deviations found with regard to the normal
use of the items, materials, or products concerned

Details:
Management defines the minimum levels of qualification and experience necessary for
all posts within the laboratory. In some technical areas it may be required that the
personnel performing certain tasks be certified. The laboratory is responsible for fulfilling
specified certification requirements of personnel. The requirements for personnel
certification might be regulatory, might be included in the standards for the specific
technical field, or required by the customer.

Continued competence is monitored and where this is not achieved, the need to retrain
personnel is considered. Where a method or technique is not in regular use, verification
of personnel performance before they undertake tests, may be necessary.

5.2.2 Training Policies and Procedures


Policy:
Management will formulate the goals with respect to the education and the skills of the
laboratory personnel. The training program is relevant to the present and anticipated tasks
of the laboratory. SOP# QSP 5-2-1 is utilized to identify training needs and providing the
necessary training for personnel. The effectiveness of the training actions taken are
evaluated.

Details:
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The skills and knowledge are defined in the job description for each job function as
described in section 5.2.4. Management compares the job description to the skills and
knowledge of the new incumbent to determine the training needs.

Training in the laboratory must include all methods or parts of methods and techniques
that personnel are asked to perform. Minimally, the analyst must demonstrate
competency through observation by management and verification using replicate and/or
check samples. For technicians who perform only parts of the method, confirmation of
competency may be verified by observation only. Re-verification of all personnel must be
performed annually on all methods or techniques pertinent to their job description.

In some cases it may be appropriate to define competence related to a particular


technique or instrument rather then methods. If so, it will be necessary to define for each
method, the necessary technique-based competence required together with any additional
requirements.

5.2.3 Employees
Policy:
Competent permanent or contractual employees are employed in the laboratory. The
Laboratory Director ensures that contractual, additional technical employees, and key
support personnel are supervised and work in accordance to the policies and procedures
of this Quality Manual.

Details:
Testing must be either performed or supervised by an experienced person qualified to
degree level.

5.2.4 Job Descriptions


Policy:
Current job descriptions for managerial, technical and key support personnel involved in
tests and/or calibrations are maintained centrally in the administration area of the
laboratory.

Details:
Minimum contents of job descriptions include:
¾ the duty of performing tests and/or calibrations
¾ the act of planning tests and/or calibrations and evaluation of results
¾ the responsibility of developing and validating new methods as / when requested
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¾ expertise and experience


¾ qualifications and training programs
¾ managerial duties

5.2.5 Authorized Personnel


Policy:
Management authorizes specific personnel to perform particular types of sampling, test
and/or calibration, to issue test reports, to give opinions and interpretations and to operate
particular types of equipment. Records of the relevant competence, educational and
professional qualifications, training, skills and experience of all technical personnel and
contracted personnel are maintained. This information is readily available and includes
the date on which authorization and/or competence was confirmed and the criteria on
which the authorization is based and the confirming authority.

Details:
The purpose of these records is to provide evidence that personnel have been adequately
trained and their competence to perform particular tests has been assessed. In some cases
it may be pertinent to state any particular limitations to competence. The records are
maintained in a registry of skills and include:
¾ academic and professional qualifications
¾ external and internal courses attended
¾ relevant on-the-job training and retraining as necessary (i.e., demonstration of
competence)
¾ skills and experience (i.e., resume)
¾ relevant authorizations

Records are held centrally in the administration area.

Revision History
Revision 1 - Job Description (details section) was updated to reflect current policies.
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Section 5.3 – Accommodation and Environmental Conditions
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5.3 Accommodation and Environmental Conditions

The Ten Second Tutorial


This section tells you:

1. That laboratory facilities are suitable for attaining correct


performance of tests and calibrations
2. Critical environmental conditions are monitored, controlled and
recorded
3. Incompatible activities are separated
4. Access to laboratories is controlled
5. Good housekeeping is practiced

Key Words
Incompatible activities
Prevent cross-contamination
Controlled access

Cross-references
ISO 17025:2005 Section 5.3

ISO 9001:2000 Section 6.3, 6.4, 7.1, 7.5.1, 7.5.2, 7.6, 8.2.3
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5.3.1 Facility
Policy:
Laboratory facilities are appropriate to attain correct performance of tests and/or
calibrations. This may include, but not limited to, energy sources, lighting, heating,
ventilation and any other environmental conditions.

Appropriate care is taken to ensure that the environment does not invalidate the results or
adversely affect the required quality of any measurement. Particular care is taken when
sampling, tests and/or calibrations are undertaken at sites other than a permanent
laboratory facility. The technical requirements for accommodation and environmental
conditions that can affect the results of tests and calibrations are documented.

Details:
This section deals with the test areas in the laboratory and premises for support such as
sample receipt and storage. Central laboratory supplies and services, such as water
purification systems, air supply, vacuum source, and sample storage, are appropriate to
facilitate proper performance of tests.

5.3.2 Monitoring
Policy:
Critical environmental conditions are monitored, controlled and recorded as required by
the relevant specifications, methods, and procedures or where they may influence the
quality of the results. Due attention is paid, for example, to biological sterility, dust, air
quality, humidity, electrical supply, temperature, and sound and vibration levels, as
appropriate to the technical activities concerned. Tests and calibrations are stopped when
the environmental conditions jeopardize the results of the tests and/or calibrations.

Details:
Laboratories are ventilated to reduce the levels of contamination, lower humidity, and
control temperature. Laboratories’ test areas are air-conditioned or heated where
appropriate to maintain acceptable humidity and temperature conditions, relative to the
type of testing in each respective area of the laboratory.

Bench tops and floors are made of impervious, smooth easily cleaned materials. There is
at least two linear meters workspace per analyst while working. Walls and ceilings are
made of materials that are smooth and easily cleaned. In the Microbiology area, critical
work surfaces are monitored for pathogens where pertinent to the scope of the laboratory.

5.3.3 Separation of Incompatible Activities


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Policy:
Effective separation between neighboring areas is made when the activities are
incompatible. Measures are taken to prevent cross-contamination.

Details:
Reference materials and certified reference materials must be kept separated from
samples (log-in and storage). Sample log-in and storage must be segregated, ideally in a
separate area from the testing laboratory, and include proper sanitation to exclude the
possibility of cross-contamination. Segregation of activities is achieved through time and
space allocations.

An example of space segregation would be for a trace analysis. Physical separation of the
trace analysis from high-level analysis is achieved through the use of separate rooms.

An example of time segregation would be the coordination of activities at different times.


It may be appropriate to perform work on “cleaner” samples first before starting “dirtier”
type samples.

5.3.4 Controlled Access


Policy:
Access to and use of areas affecting quality of the tests and/or calibrations is defined and
controlled.

Details:
Access to the laboratory is restricted to authorized personnel. The authorized personnel
are made aware of the following items:
¾ the intended use of the area
¾ the restrictions imposed on working within such areas
¾ the reasons for imposing the restrictions

5.3.5 Good Housekeeping


Policy:
Measures are taken to ensure good housekeeping in the laboratory. Special procedures
are prepared when necessary.

Details:
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Controlled use of cleaning and pest control materials is exercised. The laboratory
complies with the local health and safety requirements.

Revision History
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Section 5.4 – Test and Calibration Methods and Method Validation
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5.4 Tests and Calibration Methods and Method Validation

The Ten Second Tutorial


This section tells you:

1. Preference is given to the use of a standard method when


selecting procedures
2. All methods must be validated before use
3. Measurement uncertainty is estimated
4. Data is controlled

Key Words
Standard Methods
Laboratory-Developed Methods
Non-standardized Methods
Validation
Uncertainty of Measurement
Data Checks

Cross-references
ISO 17025:2005 Section 5.4

ISO 9001:2000 Section 4.2.1, 4.2.3, 6.1, 6.3, 6.4, 7.1, 7.2.1, 7.2.2,
7.3, 7.4.3, 7.5.1, 7.5.2, 7.6, 8.1, 8.2.3, 8.2.4
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5.4.1 General
Policy:
Methods and procedures used for all tests and/or calibrations are appropriate as per:
¾ sampling, handling, transport, storage, and preparation of items to be tested and/or
calibrated
¾ an estimation of the measurement of uncertainty as well as statistical techniques for
analysis of test and/or calibration data where appropriate

Instructions on the use and operation of all relevant equipment and on the handling and
preparation of items for testing and/or calibration are available. All instructions,
standards, manuals and reference data relevant to the work of the laboratory are
maintained current and readily available to personnel. Deviation from test and calibration
methods must be documented, technically justified, authorized, and accepted by the
customer.

Details:
There are SOPs for sampling, sample handling, transport, storage, preparation of test
items, QA/QC procedures (media QC, incubation times and temperatures, equipment
calibration and maintenance, process control QC), and standards for approving / rejecting
results. These may be combined with or separate from the method. The content of a test
method includes:
¾ scope
¾ description of test items
¾ holding times
¾ quantities to be tested
¾ materials and equipment required
¾ physical environmental conditions required (incubation times and temperatures, pH
requirements)
¾ description of procedures
¾ sample identification
¾ method of recording observations and results
¾ safety measures
¾ documentation
¾ method for data analysis and presentation
¾ sensitivity of method
¾ quality control plan

International, national, or regional standards or other recognized specifications that


contain sufficient and concise information on how to perform the tests and/or calibrations
are not necessarily supplemented or rewritten as an internal procedure when they are
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written in a way that can be used as published by laboratory staff. Consideration may
need to be given to providing additional documentation for optional steps in the method.

5.4.2 Selection of Methods


Policy:
Test and/or calibration methods, including methods for sampling, meet the needs of the
customer and are appropriate for the tests and/or calibrations it undertakes. Preference is
given to reference methods published as international, national, or regional standards.
The laboratory ensures that the latest edition of a standard is used unless it is not
appropriate or possible to do so. When necessary, the standard is supplemented with
additional details to ensure consistent application.

Details:
Methods that have been published either in international, national, or regional standards,
or by reputable technical organizations, or in relevant scientific texts or journals, or as
specified by the manufacturer are selected when the customer does not specify the
method to be used. These methods may be adopted from the AOAC, FDA BAM, USDA
FSIS & AMS, APHA SMEDP, APHA Compendium of Methods for the Microbiological
Examination of Foods, ISO, ICMSF, National Food Processors, American Association of
Cereal Chemists, Association of Dressing and Sauces, Health Canada, Environmental
Protection Agency, OIE, ASTM, etc.

The ability of the laboratory to achieve satisfactory performance against documented


performance characteristics is verified before samples are analyzed.

Laboratory-developed methods or methods adopted by the laboratory may also be used if


they are appropriate for the intended use and if they are validated. The customer is
informed as to the method chosen. The laboratory confirms that it can properly operate
standardized methods before introducing the tests or calibrations. If the standardized
method changes, the confirmation is repeated.

The customer is informed when the method proposed by the customer is considered to be
inappropriate or out of date.

5.4.3 Laboratory-Developed Methods


Policy:
Introduction of test and calibration methods developed internally is a planned activity and
is assigned to qualified personnel equipped with adequate resources. Plans are updated as
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development proceeds and ensures effective communication amongst all personnel


involved.

Details:
Methods developed in-house are validated and authorized before use. Where available,
Certified Reference Materials (CRMs) are used to determine any systemic bias, or where
possible results are compared with other techniques, preferably based on different
principles of analysis. Determination of uncertainty must be part of this validation
process and is essential for ongoing quality control.

5.4.4 Non-Standard Methods


Policy:
Utilization of non-standard methods is subject to agreement with the customer and
includes a clear specification of the customer’s requirements and the purpose of the test.
The developed method is validated appropriately before use.

Details:
Discussion and agreement for the use of non-standard methods is recorded as part of
contract review procedures (see section 4.4).

All non-standard and new tests are validated for their intended purpose. Qualitative test
methods must be validated to demonstrate estimated sensitivity and specificity, relative
accuracy to official methods (if appropriate), positive and negative deviation, limit of
detection, matrix effect, repeatability, and reproducibility.

Quantitative test methods are validated to demonstrate specificity, sensitivity, relative


accuracy, positive and negative deviation, repeatability, reproducibility, and limit of
determination.

For new methods where procedures are developing rapidly, especially for emergency
situations, it may be necessary to circumvent normal validation procedures. Minimally,
this must be a demonstrated recovery in replicate.

New test and/or calibration methods are documented prior to providing test and/or
calibration results to customers and contain at least the following information:
¾ appropriate identification
¾ scope
¾ description of the type of item to be tested or calibrated
¾ parameters or quantities to be determined
¾ apparatus and equipment, including technical performance requirements
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¾ reference standards and reference materials required


¾ environmental conditions required and any stabilization period needed
¾ description of the procedure, including:
¾ affixing identification marks, handling, transporting, storing and preparing of
items
¾ ensuring checks are made before the work is started
¾ checking that the equipment is working properly and, where required, calibrating
and adjusting the equipment before each use
¾ listing method of recording the observations and results
¾ indicating any safety measures to be observed
¾ criteria and/or requirements for approval/rejection (quality control plan)
¾ data to be recorded and method of analysis and presentation
¾ uncertainty or procedure for estimating uncertainty

5.4.5 Validation of Methods


5.4.5.1 Performance Characteristics

Policy:
Validation of a method establishes, by systematic laboratory studies, that the performance
characteristics of the method meet the specifications related to the intended use of the test
results.

Details:
The performance characteristics of a validation plan includes, as applicable:
¾ selectivity and specificity
¾ range
¾ linearity
¾ sensitivity
¾ limit of detection
¾ limit of quantitation
¾ accuracy
¾ precision
¾ reporting limit
¾ repeatability
¾ reproducibility
¾ recovery
¾ confirmation techniques
¾ criteria for the number of samples tested to validate method as per defined scope of
method
¾ action levels where defined by regulation
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¾ quality control incorporating statistics as applicable


¾ interpretation of population results as applicable

Performance characteristics that are selected take into account the intended use of the
method, whether for screening, confirmatory analysis, or quantitation.

The design, verification of the method and documentation procedures for validation are
planned and conducted by qualified personnel, equipped with adequate resources.

This section lists a few acceptable validation procedures. The choice of the procedure
depends on the extent of the deviation from the published method.

Validation of methodology is a value judgment in which the performance parameters of


the method are compared with the requirements for the test data. A prerequisite for a
valid method is that data produced by the method must attain a state of statistical control.
Such a state is obtained when the mean value of a large number of individual values tends
to approach a limiting value called the limiting mean.

Methods may be validated by one or more alternative procedures. Some of these


procedures are described below. Apparent differences can be analyzed statistically to
confirm their significance. In all cases, the reasons for choosing one or more alternatives
must be documented.
¾ analysis of standard reference materials (SRM) that are identical or almost identical to
the test samples
¾ in the absence of suitable SRMs, analysis of reference materials that are similar in all
respect to the test samples; the use and validity of this reference material must be
documented
¾ using an alternative method to measure the same parameter provides a very high level
of confidence if results are confirmed
¾ recovery studies by the addition of a known concentration of the parameter of interest
to some of the replicates being measured

The parameters to be determined include:


¾ the scope of the method and any known interference
¾ detection limit
¾ the range of concentration where the method is valid
¾ precision and bias
¾ intra-laboratory variations
¾ inter-laboratory variations

Judgment is required to determine if some or all of the above is required. Requirements


will depend largely on the extent of deviation from the original method.
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Developments in methodology and techniques require methods to be changed from time


to time. The difference in performance between revised and obsolete methods is
established so that it is possible to compare old and new data.

Where a change in method involves only minor adjustments, such as sample size, or
different reagents, the amended method is validated and the changes brought to the
attention of the accreditation body at the next accreditation audit. Where the proposed
change involves technology or methodology, the laboratory seeks the approval of the
accreditation body.

Records are kept on all validation activities. The records include any of the performance
characteristics chosen, reference procedures or guidance documents followed to validate
the method or custom validation procedure, and a final confirmation (memo to file) that
the method validation results are acceptable for continued use of the method. An example
statement would be “This memo serves as record that the validation of the XYZ Test
Method has been approved for use by [name and title of approver]”.

5.4.5.2 Fit for Use

Policy:
The laboratory validates non-standardized methods, laboratory-designed/developed
methods, standardized methods used outside their intended range, and amplifications of
standard methods to confirm that the methods are fit for the intended use. The validation
is as extensive as is necessary to meet the needs in the given application or field of
application (may include procedures for sampling, handling, and transportation). The
laboratory records the results obtained, the procedure used for the validation, and a
statement as to whether the method is fit for the intended use.

Details and Procedure:


Validation records are kept as in section 5.4.5.1. Included in these records is the
validation procedure. The procedure used for the validation is likely to vary between
different methods. Therefore, the procedures included in the laboratory records are not as
detailed as a typical SOP, but are sufficient enough to re-create how the method was
validated.

The techniques used for the determination of the performance of a method, are one of, or
a combination of, the following:
¾ calibration using reference standards or reference materials
¾ comparison of results achieved with other methods
¾ inter-laboratory comparisons
¾ systematic assessment of the factors influencing the result
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¾ assessment of the uncertainty of the results based on scientific understanding of the


theoretical principles of the method and practical experience.

When changes are made in the validated non-standard method, the influence of such
changes carried out is documented and if appropriate a new validation is performed.

5.4.5.3 Customer’s Needs

Policy:
The range and accuracy of the values obtainable from validated methods (e.g., the
uncertainty of the results, detection limit, selectivity of the method, linearity, limit of
repeatability and/or reproducibility, robustness against external influences and/or cross-
sensitivity against interference from the matrix of the sample/test object) as assessed for
the intended use is relevant to the customer’s needs.

Details:
Validation includes the specification of the requirements, determination of the
characteristics of the methods, the comparison of the requirements with the values of the
characteristics of the method, and a statement on the validity.

As method development proceeds, regular review is required to verify that the needs of
the customer are still being fulfilled. Changing requirements requiring modifications to
the development plan are approved and authorized.

Validation is always a balance between costs, risks, and technical possibilities.

5.4.6 Uncertainty of Measurement


5.4.6.1 Calibration

Policy:
Physical, chemical, and biological standards are calibrated or characterized by qualified
subcontractors.

Details and Procedures:


Repeatability and reproducibility data are components of measurement uncertainty and
are determined as a first step towards producing estimates of this parameter. The
uncertainty of measurement is available on the certificate of analysis or calibration
certificate from a subcontractor.
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Note – in-house calibrations include procedures for uncertainty of measurement


estimates where this is common practice.

5.4.6.2 Testing

Policy:
The SOP# QSP 5-4-1 is utilized to estimate uncertainties of measurement in testing,
except when the test methods preclude such rigorous calculations. In certain cases it is
not possible to undertake metrologically and statistically valid estimations of uncertainty
of measurement. In these cases the laboratory attempts to identify all the components of
uncertainty and make the best possible estimation, and ensure that the form of reporting
does not give an exaggerated impression of accuracy. Reasonable estimation is based on
knowledge of the performance of the method and on the measurement scope and makes
use of previous experience and validation data.

Details:
The degree of rigor needed in an estimation of uncertainty of measurement depends on
factors such as:
¾ requirement of the test method
¾ requirement by the customer
¾ if there are narrow limits on which decisions on conformity to a specification are
based

In cases where a well-recognized test method specifies limits to the values of the major
sources of uncertainty of measurement and specifies the form of presentation of
calculated results, the laboratory is considered to have satisfied the estimation uncertainty
of measurement by following the reporting instructions (see section 5.10).

5.4.6.3 Uncertainty Components

Policy:
When estimating the uncertainty of measurement, all uncertainty components that are of
importance in the given situation are taken into account using accepted methods of
analysis.

Details:
Sources contributing to the uncertainty include, but are not necessarily limited to, the
reference standards and reference materials used, methods and equipment used, the
environmental conditions, the item being tested or calibrated and the operator.
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The predicted long-term behavior of the tested and/or calibrated item is normally not
taken into account when estimating the measurement uncertainty.

For further information, see ISO 5725 and the Guide to Expression of Uncertainty in
Measurement.

5.4.7 Control of Data


5.4.7.1 Calculations and Data Transfers

Policy:
Calculations and data transfers are subject to appropriate checks in a systematic manner.

Details:
Test data are validated through the following arrangements by the: Area Supervisor
¾ checks to determine accuracy of calculations, conversions, and data transfers
¾ checks for transcription errors, omissions, and mistakes
¾ checks to determine consistency with normal or expected values

For those analyses where manual data reduction is required, it is performed according to
the instructions provided in the test method or SOP.

5.4.7.2 Computers and Automated Equipment

Policy:
When computers or automated equipment are used for the acquisition, processing,
manipulation, recording, reporting, storage or retrieval of test or calibration data, the
laboratory ensures that:
¾ computer software developed by the user is documented in sufficient detail and
suitably validated or otherwise checked as being adequate for use
¾ procedures are established and implemented for protecting the integrity of data; such
procedures include, but are not be limited to, integrity and confidentiality of data
entry or collection, data storage, data transmission, and data processing (see section
4.13.1.4)
¾ computers and automated equipment are maintained to ensure proper functioning and
are provided with the environmental and operating conditions necessary to maintain
the integrity of test and calibration data
¾ data is securely maintained by preventing unauthorized access to, and unauthorized
amendment of, computer records
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Details and Procedures:


Data generated using computer software programs that are interfaced directly to
instruments incorporates all dilutions and calculations, thereby eliminating the need for
manual data reduction.

Commercially developed software in general use within its designed application range
may be considered sufficiently validated. Laboratory software configuration /
modifications are validated as outlined in SOP# QSP 5-5-1.

Electronic records, electronic signatures, and handwritten signatures executed to


electronic records must be equivalent to proper records and handwritten signatures to
paper and are validated by procedures in 21 CFR. Part II (Docket No. 92NO251)
RIN0910-AA29; Federal Register: March 20, 1997, Volume 62, Number 54), Rules and
Regulations, pages 13429-13466. For further details see:

http://www.fda.gov/ora/compliance_ref/part11/

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Section 5.5 – Equipment
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5.5 Equipment

The Ten Second Tutorial


This section tells you to:

1. Identify information needs for accept / reject decisions


2. Install equipment capable of providing that information
3. Use the equipment in the proper environment
4. Periodically check the equipment calibration

Key Words
Required Equipment and Accuracy
Authorized Personnel
Unique Identification
Inventory
Maintenance
Procedures
Out of Service
Calibration Status
Re-verification
Checks
Correction Factors
Safeguards against Adjustment

Cross-references
ISO 17025:2005 Section 5.5

ISO 9001:2000 Section 4.2.1, 4.2.3, 5.1, 6.2.2, 6.3.1, 7.1, 7.4,
7.5.1, 7.5.2, 7.5.3, 7.6, 8.1, 8.2.3, 8.2.4
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5.5.1 Required Equipment


Policy:
The laboratory is furnished with all items for sampling, measurement and test equipment
required for the correct performance of the tests and/or calibrations (including sampling,
preparation of test and/or calibration items, processing and analysis of test and/or
calibration data). When equipment is used outside the laboratory’s permanent control, it
ensures that the requirements of this Quality Manual are met.

Details:
Equipment is used in an environment appropriate to its proper performance. All
equipment required by a test is described in each method, including the equipment’s
tolerances.

5.5.2 Required Accuracy


Policy:
Equipment and software used for testing, calibration and sampling are capable of
achieving the accuracy required and comply with specifications relevant to the tests
and/or calibrations concerned. Calibration programs are established for key quantities or
values of the instruments where these properties have a significant affect on the results.
When received, equipment, including that used for sampling, is checked to establish that
it meets the laboratory’s specification requirements, complies with the relevant standard
specifications, and is checked and/or calibrated in accordance with section 5.6 before use.

Details:
The procedures for checking newly received equipment are as determined by
manufacturers’ specification and/or those determined by the laboratory during
procurement.

5.5.3 Authorized Personnel


Policy:
Equipment is operated by authorized personnel. Up-to-date instructions on the use and
maintenance of equipment (including any relevant manuals provided by the manufacturer
of the equipment) are readily available for use by the appropriate laboratory personnel.

Details:
Access to laboratory equipment is controlled to ensure that only authorized personnel use
equipment.
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5.5.4 Unique Identification


Policy:
Each item of equipment used for testing and calibration is uniquely identified as
appropriate.

Details:
Measuring and testing equipment is uniquely identified through asset identification.
Measuring and testing equipment includes any instrument that could affect the quality of
test results. Components that can be interchanged between various instruments are
tracked in equipment logbooks but are not assigned individual asset identifications.

5.5.5 Inventory and Maintenance Records


Policy:
Records are maintained for each item of equipment significant to the tests and/or
calibrations performed. The records include the following:
¾ identity of the item of equipment (and its software)
¾ manufacturer’s name, type identification, and serial number and/or other unique
identification
¾ checks that equipment complies with the specification (see section 5.5.2)
¾ current location, where appropriate
¾ the manufacturer’s instructions, if available, or reference to their location
¾ dates, results and copies of reports and certificates of all calibrations, adjustments,
acceptance criteria, and due date of next calibration
¾ maintenance carried out to date and the maintenance plan (includes calibration)
¾ damage, malfunction, modification or repair to the equipment

Details:
A database is used to capture the above inventory information. The above information
related to service and maintenance is kept in individual equipment files and/or binders.
Other information kept in these files and/or binders may include:
¾ date received and date placed in service
¾ condition when received (e.g., new, used, refurbished)
¾ dates and results of calibration and/or verification and date of next calibration and/or
verification
¾ performance history, where appropriate (e.g., response time, drift, noise level)
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5.5.6 Equipment Procedures


Policy:
The SOP# QSP 5-5-1 is utilized as an established plan for safe handling, transport,
storage, use and maintenance (including calibration) of measuring equipment, and
appropriate use of correction factors to ensure proper functioning and in order to prevent
contamination or deterioration.

Note – additional procedures may be necessary when measuring equipment is used


outside the permanent laboratory for tests, calibrations, or sampling (currently not
applicable at our laboratory).

Details and Procedures:


The procedures for each piece of measuring equipment are located in the appropriate
room where the equipment is located (or in a centralized library). These procedures detail
any information for safe handling, transport, storage, use, and maintenance of measuring
equipment.

5.5.7 Out of Service Equipment


Policy:
Equipment that has either been subjected to overloading or mishandling, or gives suspect
results, or has been shown to be defective or outside specified limits, is taken out of
service, clearly marked, and appropriately stored until it has been repaired and shown by
calibration or test to perform correctly.

Details:
Routine testing work is completely discontinued on equipment that even shows minor
nonconformances. Not only do we do this for ethical reasons in support of our customer,
but minor nonconformances are often indicative of major breakdowns in expensive
equipment. These breakdowns need to be avoided wherever possible.

Out of service equipment is clearly marked as outlined in section 5.5.8.

The laboratory examines the effect of the defect or departure from specified limits on
previous test and/or calibrations and institutes the “Control of Nonconforming Work”
procedure as outlined in section 4.9.

5.5.8 Calibration Status


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Policy:
Equipment requiring calibration is labeled to indicate the calibration status and/or
operational status and the date when re-calibration is due when appropriate.

Details:
Calibration labels have a write-on surface and a pressure sensitive adhesive. The areas
that are filled out include the person who performed the calibration, the date it was
performed, the date it is due for re-calibration, and the equipment’s identification
number.

CALIBRATION
BY DATE
DUE ID#

Measuring equipment that has failed calibration or is deemed out of service is labeled
with one of the following labels:

CALIBRATION VOID OUT OF SERVICE

DO NOT USE DO NOT USE

A piece of equipment that is not calibrated or checked is labeled with the following label:

FOR REFERENCE ONLY

5.5.9 Return to Service


Policy:
When equipment goes outside the direct control of the laboratory for a period, the
laboratory ensures that the function and calibration status of the equipment are checked
and validated and shown to be satisfactory before the equipment is returned to service.

Details and Procedures:


The procedures used to check and ensure that the function and calibration status of the
equipment are satisfactory before the equipment is returned to service are outlined in the
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manufacturer’s equipment manual. Any additional quality control checks are outlined in
the “Quality Control Plan” section of the appropriate test method.

5.5.10 Periodic Checks


Policy:
When intermediate checks are needed to maintain confidence in the calibration status of
equipment, these checks are carried out periodically according to defined procedure.

Details and Procedures:


As stated in section 5.5.6, the procedures for each piece of measuring equipment are
located in the appropriate room where the equipment is located (or in a centralized
library). SOP# QSP 5-5-1 outlines a general maintenance plan for equipment and
includes various checks. Internal quality control checks are specified in individual test
methods that are located in the appropriate laboratory areas thereby providing procedures
for intermediate checks.

5.5.11 Correction Factors


Policy
Calibrations that give rise to a set of correction factors are updated along with all copies
of this data (e.g., in computer software).

Details and Procedures:


The updating of correction factors, including all copies, is assured by following the
appropriate test method or SOP. It is the responsibility of the Area Supervisor to ensure
that all copies are updated.

5.5.12 Safeguards against Adjustments


Policy:
Test and calibration equipment, including hardware and software, are safeguarded from
adjustments that invalidate test and/or calibration results/status.

Details:
Safeguards against adjustment for laboratory equipment include:
¾ detailed SOPs and manufacturer’s manuals on the operation of the equipment
¾ policies permitting only fully trained and competent personnel to operate equipment
¾ access to the laboratory is restricted to authorized personnel
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Safeguards against adjustment for software includes:


¾ password protection for important files and packages
¾ access to the laboratory is restricted to authorized personnel

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5.6 Measurement Traceability

The Ten Second Tutorial


This section tells you:

1. Measurements are traceable to SI units (when applicable)


2. Reference Standards and Reference Materials are used

Key Words
Systèm International
Reference Standard
Reference Material
Traceability

Cross-references
ISO 17025:2005 Section 5.6

ISO 9001:2000 Section 6.3.1, 7.1, 7.5.1, 7.6


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5.6.1 General
Policy:
Test and/or calibration equipment for subsidiary measurements (e.g., for environmental
conditions) having a significant effect on the accuracy or validity of the result of the test,
calibration, or sampling are calibrated before being put into service. All measurement and
test equipment having an effect on the accuracy or validity of tests is calibrated and/or
verified before being put into service. As mentioned in section 5.5, the SOP# QSP 5-5-1
outlines an established program for the maintenance of equipment and includes calibration.

Details:
The program includes a system for selecting, using, calibrating, checking, controlling, and
maintaining:
¾ measurement standards
¾ reference standards used as measurement standards
¾ measuring and test equipment used to perform tests and calibrations

Procedures are documented where appropriate. All measurements that play a defining role
in testing accuracy are based directly or indirectly on reference standards, reference
materials, certified reference materials, or other standards or materials having appropriate
traceability.

Records are maintained for each standard. These records include, as applicable:
¾ supplier, grade, batch#
¾ dates of preparation or verification
¾ measurement of weights, volumes, time intervals, temperatures, and pressures and
related calculations
¾ relevant processes (e.g., pH adjustment, sterilization)
¾ verification results
¾ identification of personnel involved

Records are maintained for each lot of test organisms. These records include, as applicable:
¾ species and ATCC#
¾ maintenance history

Disposal of test organisms is carried out humanely and conforms to applicable legal
requirements.

Reagents prepared in the laboratory are labelled to identify substance, strength, solvent
(where not water), any special precautions or hazards, restrictions of use, and date of
preparation and/or expiry. The person responsible for the preparation of the reagent is
identified either from the label or from records.
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5.6.2 Specific Requirements


5.6.2.1 Calibration

Policy:
The program for calibration equipment is designed and operated to ensure that calibration
measurements are traceable to the Système International (SI) units of measurement.

Details:
Traceability of measurement is assured by the use of calibration services from laboratories
that can demonstrate competence, measurement capability and traceability. The calibration
certificates issued by these laboratories show that there is a link to a primary standard or to a
natural constant realizing the SI unit by an unbroken chain of calibrations. The calibration
certificates contain the measurement results including the measurement uncertainty and/or a
statement of compliance with an identified metrological specification (see also section
5.10.4.2).

Calibration laboratories accredited to ISO 17025 are considered competent to provide the
appropriate calibration services.

Traceability to SI units of measurement may be achieved by reference to an appropriate


primary standard or by reference to a natural constant the value of which, in terms of the
relevant SI unit, is known.

The term “identified metrological specification” means that it must be clear from the
calibration certificate against which specification the measurements have been compared
with, by including the specification or by giving an unambiguous reference to the
specification.

When the terms “international standard” or “national standard” are used in connection with
traceability, it is assumed that these standards fulfill the properties of primary standards for
the realization of SI units.

Maintain certificates of all reference standards, measuring equipment, or certified reference


material used in ensuring traceability. Where traceability to national standards of
measurement is not applicable, the laboratory provides satisfactory evidence of correlation
of results, for example by participation in a suitable program of inter-laboratory
comparisons or proficiency testing.
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Reference standards, such as thermometers and weights, are traceable to a national or


international standard (e.g., NIST).

5.6.2.2 Testing

5.6.2.2.1

Policy:
The requirements given in section 5.6.2.1 apply to measuring and test equipment with
measuring functions used, unless it has been established that the associated calibration
uncertainty contributes little to the total uncertainty of the test result. When this situation
arises, the laboratory ensures that equipment used can provide the accuracy of measurement
needed.

Details:
The extent to which the requirements in section 5.6.2.1 are followed depends on the relative
contribution of calibration uncertainty to the total uncertainty. If calibration is the dominant
factor, the requirements are strictly followed. If, however, calibration is not one of the major
contributors to the total uncertainty, other ways for providing confidence may be used, as
given in section 5.6.2.2.2.

5.6.2.2.2

Policy:
Where traceability to SI units of measurement is not possible and/or not relevant, other
means for providing confidence in the results are applied such as:
¾ the use of suitable reference materials certified to give a reliable characterization of the
material
¾ mutual-consent standards or methods which are clearly specified and agreed upon by all
parties concerned
¾ participation in a suitable program of inter-laboratory comparisons or proficiency testing

Details:
Reliable characterization involves an estimate of recovery.

The laboratory participates in proficiency testing and/or check sample programs. The list of
programs is maintained by the Quality Manager.

5.6.3 Reference Standards and Reference Materials


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5.6.3.1 Reference Standards

Policy:
The SOP# QSP 5-6-1 outlines the program for the calibration of reference standards.
Reference standards are obtained or calibrated by a body that can provide traceability as
described in section 5.6.2.1. Such reference standards of measurement held by the
laboratory are used for calibration only and for no other purpose, unless it can be shown that
their performance as reference standards would not be invalidated.

Details:
Reference standards are obtained from the National Institute of Standards and Technology
(NIST) if applicable.

5.6.3.2 Reference Materials

Policy:
Where possible, reference materials are traceable to SI units of measurement, or to certified
reference materials. Internal reference materials are checked as far as is technically and
economically practicable.

Details:
Reference materials, including calibration standards, used in chemical measurement are
prepared so that the point of measurement is similar or equivalent to that of the samples. The
matrix, prior to the addition of the analyte does not have a detectable concentration of the
analyte. Reagents used in the preparation of reference materials, including calibration
standards are of certified purity.

Certified reference cultures are traceable to a national or internationally recognized type


culture collection. Reference cultures from laboratory sources must be identified to standard
reference sources. These reference cultures must be handled to maintain their biochemical
reaction and physiological characteristic integrity. All Reference Cultures and Certified
Reference Cultures are not transferred more than five times from a type culture collection.
Alternatively, re-identify the culture for key biochemical and physiological characteristics
using national or internationally recognized reference sources. Another alternative is to grow
the type culture, then freeze it (or freeze-dry it), and use periodically. Thus, extending the
length of time required before repurchase or re-identification. These may also be
commercially available and purchased for use. Companies selling Certified Reference
Cultures must comply with the requirements of ISO 17025 for a calibration laboratory.

5.6.3.3 Intermediate Checks


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Policy:
Checks needed to maintain confidence in the calibration status of reference, primary,
transfer or working standards and reference materials are carried out according to defined
procedures and schedules.

Details and Procedures:


The control check standards used to verify the accuracy of all the other standards are
prepared independently from all the other standards used to establish the original calibration.
These control check standards are preferably prepared from a separate lot # or source. It is
the responsibility of the Area Supervisor to establish and maintain the individual schedule
for each SOP and/or test method.

5.6.3.4 Transport and Storage

Policy:
The SOP# QSP 5-6-1 outlines safe handling, transport, storage and use of reference
standards and reference materials in order to prevent contamination or deterioration and in
order to protect their integrity.

Details:
Additional procedures may be necessary when reference standards and reference materials
are used outside the permanent laboratory for tests, calibrations, or sampling.

Proper conditions are established for housing, handling, and care of reference standards,
reference materials, and test organisms. Test organisms are acclimatized to the test
environment for an adequate period before a test is initiated. All information needed to
properly identify references appears on their housing or containers.

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Section 5.7 – Sampling
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5.7 Sampling

The Ten Second Tutorial


This section tells you:

1. There must be a sampling plan and procedure


2. Appropriate records of sampling are kept
3. Deviations, additions, and exclusions from the plan or procedure
are recorded

Key Words
Sampling Plan and Procedure
Deviation, Addition, or Exclusion

Cross-references
ISO 17025:2005 Section 5.7

ISO 9001:2000 Section 4.2.4, 7.5.1


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5.7.1 Sampling Plan and Procedures


Policy:
The SOP# QSP 5-7-1 outlines the sampling plan and procedures for sampling for any
laboratory sampling of substances, matrices, materials or products for subsequent testing or
calibration. The sampling plan and procedures are available at the location where sampling
is performed. Sampling plans are based on appropriate statistical methods whenever
reasonable. The sampling process addresses the factors to be controlled to ensure validity of
the test and calibration results.

Details:
Sampling is a defined procedure whereby a part of a substance, matrix, material or product
is taken to provide for testing or calibration as a representative sample of the whole.
Sampling can also be required by the appropriate specification for which the substance,
matrix, material or product is to be tested or calibrated. In certain cases (e.g., forensic
analysis), the sample may not be representative, but determined by availability.

The sampling plan describes the allocation, withdrawal and preparation of a sample or
samples from a substance, matrix, material or product to yield the required information. All
samples are collected and placed in sealed containers.

5.7.2 Deviations, Additions or Exclusions


Policy:
Where the customer requires deviations, additions or exclusions from the sampling
procedure, these are recorded in detail with the appropriate sampling data and included in all
documents containing test and/or calibration results, and communicated to the appropriate
personnel.

Details:
The physical appearance and temperature of all test items is observed and recorded upon
receipt. Any deviations from specifications or observations are discussed with the customer
as to the suitability of the sample. Cross-contamination is the most critical issue from
broken, leaking samples for both qualitative and quantitative tests.

5.7.3 Records
Policy:
The SOP# QSP 5-7-1 outlines the procedures for recording relevant data and operations
relating to sampling that forms part of the testing or calibration that is undertaken. These
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records include the sampling procedure used, the identification of the sampler,
environmental conditions (if relevant) and any diagrams or other equivalent means to
identify the sampling location as necessary, and, if appropriate, the statistics upon which the
sampling procedures are based.

Details:
Adequate sample identification upon receipt in the laboratory includes:
¾ unique and unambiguous sample identification, usually a number or alphanumeric
identification, retained throughout the testing life of the test item
¾ name of person(s) the report will be sent to
¾ sample source, date, and time (if available)
¾ identification number or description from (customer) if any
¾ product description
¾ tests desired and/or methods requested
¾ date and time of receipt
¾ delivery carrier
¾ sample condition, including temperature (and number of containers)
¾ chain of custody seals ‘intact’ (where applicable)

Revision History
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Section 5.8 – Handling of Test and Calibration Items
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5.8 Handling of Test and Calibration Items

The Ten Second Tutorial


This section tells you to:

1. Keep samples in good condition.

Key Words
Identification
Receipt
Protection

Cross-references
ISO 17025:2005 Section 5.8

ISO 9001:2000 Section 6.3, 6.4, 7.1, 7.4.3, 7.5, 8.2.4


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5.8.1 Procedures
Policy:
The SOP# QSP 5-8-1 outlines the procedures for the transportation, receipt, handling,
protection, storage, retention and/or disposal of test and/or calibration items, including all
provisions necessary to protect the integrity of the test or calibration item, and the interests
of the laboratory and the customer.

Details:
Samples, reagents, and standards are stored so as to ensure their integrity by preventing
against deterioration, contamination, and loss of identity. It is recognized that this is a
general statement, but details are elaborated upon in SOP# QSP 5-8-1.

5.8.2 Identification of Test and/or Calibration Items


Policy:
Test and/or calibration items are systematically identified as they arrive at the laboratory.
The identification is retained throughout the life of the item in the laboratory. The system is
designed and operated so as to ensure that items cannot be confused physically, or when
referred to in records or other documents. The system accommodates a sub-division of
groups of items and the transfer of items within and from the laboratory when appropriate.

Details:
Sample labelling indicates the unique identification and conforms to applicable legal
requirements. Where conformity of possession of a test sample must be maintained for
forensic or other purposes, the laboratory establishes and documents a system for
appropriate chain-of-custody (forensic samples may be used in a court of law for evidentiary
purposes).

5.8.3 Receipt
Policy:
Upon receipt of the test or calibration item, any abnormalities or departures from normal or
specified conditions, as described in the relevant test or calibration method, are recorded.
When there is any doubt as to the suitability of an item for test or calibration, or when an
item does not conform to the description provided, or the test or calibration required is not
specified in sufficient detail, the laboratory consults the customer for further instructions
before proceeding and keeps a record of the discussion.

Details:
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Conform to applicable regulations or contractual arrangements. The condition of sample


may include or relate to damage, quantity, preparation, packaging, or temperature.
Preparation may include addition of chemical preservative, removal of moisture, isolation of
portion of sample to be tested, homogenization, or subsampling.

Arrangements are in place to ensure that elapsed time between sampling and testing does
not exceed test method specifications (holding time).

5.8.4 Protection
Policy:
The SOP# QSP 5-8-1 outlines the procedures and appropriate facilities for avoiding
deterioration, loss or damage to the test or calibration item during storage, handling and
preparation and testing; instructions provided with the item are followed. When items have
to be stored or conditioned under specified environmental conditions, these conditions are
maintained, monitored, and recorded. Where a test item is to be held secure (e.g., for reasons
of record, safety or value, or to enable complementary test and/or calibrations to be
performed later), the laboratory has arrangements for storage and security that protect the
condition and integrity of the secured item concerned.

Details:
A sampling procedure and information on storage and transport of samples, including all
information that may influence the test or calibration result, is provided to those responsible
for taking and transporting the samples.

The laboratory establishes whether the sample has received all necessary preparation or
whether the customer requires preparation to be undertaken or arranged by the laboratory.
Proper requirements for packaging, environmental conditions, and separation from
incompatible materials are observed. Where samples have to be stored or conditioned under
specific conditions, these conditions are maintained, monitored, and recorded, where
necessary.

Where a sample, or portion of a sample, is to be held secure (e.g., for reasons of record,
safety, or value, or to enable check tests to be performed later), the laboratory has storage
and security arrangements that protect the condition and integrity of the sample.

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Section 5.9 – Assuring the Quality of Test and Calibration Results
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5.9 Assuring the Quality of Test and Calibration Results

The Ten Second Tutorial


This section tells you:

1. That results are monitored


2. There is a plan for monitoring

Key Words
Internal Quality Control
Statistical Techniques
Inter-laboratory Comparisons
Proficiency Testing
Certified Reference Materials
Secondary Reference Material
Replicates
Re-testing
Correlation

Cross-references
ISO 17025:2005 Section 5.9

ISO 9001:2000 Section 6.3, 6.4, 7.1, 7.2.1, 7.2.2, 7.3, 7.4.3, 7.5.1,
7.5.2, 7.5.3, 7.5.5, 8.1, 8.2.3, 8.2.4, 8.4
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5.9.1 Quality Control / Quality Assurance


Policy:
Quality control procedures are utilized to monitor the validity of test and/or calibration
results. These procedures are for each test method utilized in the laboratory. The resulting
data are recorded so that trends are detectable (and where practicable, statistical
techniques are applied to the reviewing of the results). This monitoring is planned and
reviewed and may include, but not limited to, the following:
¾ regular use of certified reference materials and/or internal quality control using
secondary reference materials
¾ participation in inter-laboratory comparisons or proficiency testing programs
¾ replicate tests or calibrations using the same or different methods
¾ re-testing or re-calibration of retained items
¾ correlation of results for different characteristics of an item

Details:
The methods utilized from the above list will be appropriate for the type and volume of
the work undertaken. Records are maintained of assurance activities and any actions
taken.

As a guide, for routine analyses the level of internal quality control is typically 5% of the
sample throughput. For more complex procedures, 20% is not unusual and on occasions
even 50% may be required. For analyses performed infrequently, a full system validation
is performed on each occasion. This may typically involve the use of a reference material
containing a certified or known concentration of analyte, followed by replicate analyses
of the sample and spiked sample. For analyses undertaken more frequently, systematic
quality control procedures incorporating the use of control charts and check samples are
implemented. These procedures are documented in the "Quality Control Plan" of each
test method.

Internal quality control schemes using statistics include:


¾ design of experimental/factorial analysis
¾ variation/regression analysis
¾ safety evaluation/risk analysis
¾ tests of significance
¾ quality control charts
¾ statistical sampling inspection

Proficiency testing helps to highlight not only repeatability and reproducibility


performance between laboratories, but also systematic errors such as bias. It is important
to monitor proficiency testing results as a means of checking quality assurance and take
action as necessary.
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The Quality Manager maintains a list of all the current proficiency testing programs the
laboratory participates in, monitors the results, and notifies the appropriate personnel of
both problematic and successful results.

Technical personnel use certified reference materials (where applicable) to evaluate test
performance on a daily basis and include daily process control checks. These data are
used to evaluate the validity of the test results.

Replicate tests may be used if suitable reference material is available. These materials
and proficiency test materials are available for improving repeatability.

Re-testing of test items is performed occasionally at the discretion of the supervisor or


when test results seem anomalous.

5.9.2 Correction and Prevention


Policy and Details:
Quality control data are analyzed and, where they are found to be outside pre-defined
criteria, planned action is taken to correct and to prevent incorrect results from being
reported.

Revision History
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Section 5.10 – Reporting of Results
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5.10 Reporting of Results

The Ten Second Tutorial


This section tells you:

1. What needs to be on a report


2. How to handle amendments to reports

Key Words
Specific Information
Required Information
Interpretation
Opinion
Subcontractor
Electronic Transmission of Results
Format
Amendments

Cross-references
ISO 17025:2005 Section 5.10
ISO 9001:2000 Section 6.1, 6.3.1, 7.1, 7.2.1, 7.2.2, 7.4.3, 7.5.1,
7.5.4, 7.5.5, 8.2.4
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5.10.1 General
Policy:
The results of each test, calibration, or series of tests or calibrations are reported
accurately, clearly, unambiguously and objectively, and in accordance with any specific
instructions in the test or calibration methods.

The results are reported, normally in a test report, and include all the information
requested by the customer and necessary for the interpretation of the test results and all
information required by the method used. This information may include what is outlined
in section 5.10.2, 5.10.3 and 5.10.4.

In the case of tests or calibrations performed for internal customers, and in the case of a
written agreement with the customer, the results may be reported in a simplified way. The
information listed in section 5.10.2 to 5.10.4, and not reported, is kept readily available.

Details:
Test reports are issued as hard copy and electronic data transfer (upon request).

5.10.2 Test reports and calibration certificates


Policy:
Test reports include the following information, as appropriate:
¾ a title (e.g., “Certificate of Analysis”)
¾ name and address of laboratory, and location where tests were carried out if different
from the address of the laboratory
¾ unique identification of the test report (laboratory sample number), and on each page
an identification in order to ensure that the page is recognized as a part of the test
report, and a clear identification of the end of the test report
¾ name and address of the customer
¾ identification of the method used
¾ description, condition, and unambiguous identification of the item(s) tested
¾ date and time of receipt of test items (where this is critical to the validity and
application of the results) and date(s) of performance of the analysis
¾ reference to sampling procedures used by the laboratory or other bodies where these
are relevant to the validity or application of the results
¾ test results with, where appropriate, units of measurement
¾ the name(s), function(s) and signature(s) or equivalent of person(s) authorizing the
test report
¾ where relevant, a statement to the effect that the results relate only to the items tested
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Details:
Signing authority for test reports is the responsibility of the Client Manager. Records for
individuals with signing authority for test reports are approved by the Laboratory
Director and maintained by the Quality Manager.

Hard copies of test reports include the page number and total number of pages.

Data reported to the customer contains the appropriate significant digits for each test
method. Low level data are identified as being below specified limits.

5.10.3 Test Reports


5.10.3.1

Policy and Details:


In addition to the requirements listed in section 5.10.2, test reports include the following,
where necessary for the interpretation of results:
¾ date and time of sampling
¾ deviations from, additions to, or exclusions from the test method, and information on
specific test conditions, such as environmental conditions
¾ where relevant, a statement of compliance/non-compliance with requirements and/or
specifications
¾ where applicable, a statement on the estimated uncertainty of measurement of the test
result; information on uncertainty is needed in test reports when it is relevant to the
validity or application of the test results, when a customer’s instruction so requires, or
when uncertainty affects compliance to a specification limit
¾ where appropriate and needed opinions and interpretations (see section 5.10.5)
¾ additional information required by specific methods, customers, or groups of customers

5.10.3.2

Policy and Details:


In addition to the requirements listed in sections 5.10.2 and 5.10.3.1, test reports containing
the results of sampling include the following, where necessary for the interpretation of test
results:
¾ date of sampling
¾ unambiguous identification of substance, matrix, material or product sampled (including
name of manufacturer, model or type of designation and serial numbers as appropriate)
¾ location of sampling, including any diagrams, sketches or photographs
¾ reference to sampling plan and procedures used
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¾ details of any environmental condition during sampling that may affect the interpretation
of the test results
¾ any standard or other specification for the sampling method or procedure, and
deviations, additions to or exclusions from the specification concerned

5.10.4 Calibration Certificates


5.10.4.1

Policy:
The testing laboratory does not issue calibration certificates. However, the laboratory often
receives calibration services from a calibration laboratory and needs to be familiar with the
information on a calibration certificate.

Details:
In addition to the requirements listed in 5.10.2, the calibration certificate could include the
following, where necessary for the interpretation of calibration results:
¾ the conditions (e.g., environmental) under which the calibrations were made that have an
influence on the measurement results
¾ the uncertainty of measurement and/or a statement of compliance with an identified
metrological specification or clauses thereof
¾ evidence that the measurements are traceable (see 5.6.2.1.1)

5.10.4.2

Policy:
This section is not applicable to a testing laboratory.

5.10.4.3

Policy:
This section is not applicable to a testing laboratory.

5.10.4.4
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Policy:
A calibration certificate (or calibration label) shall not contain any recommendation on the
calibration interval except where this has been agreed with the customer or it is to be used
by the laboratory itself.

5.10.5 Opinions and Interpretations


Policy:
When opinions and interpretations are included in the test report, the basis upon which the
opinions and interpretations have been made is documented. Opinions and interpretations
are clearly marked as such in the test report.

Note - Opinions and interpretations should not be mixed-up with inspections and product
certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65.

Details:
Opinions and interpretations included in a test report may comprise, but not be limited to the
following:
¾ opinion on conformity of the results with requirements
¾ fulfilment of contractual requirements
¾ recommendations on how to use the results
¾ guidance to be used for improvements

In many cases it is appropriate to communicate the opinions and interpretations by direct


dialogue with the customer. This dialogue is written down.

5.10.6 Testing and Calibration Results Obtained from


Subcontractors
Policy and Details:
Test reports containing the results of tests performed by subcontractors are clearly identified
for the subcontracted results. The subcontractor reports the results either in writing or
electronically to our laboratory.

5.10.7 Electronic Transmission of Results


Policy:
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In the case of transmission of test results by telephone, telex, facsimile or other electronic or
electromagnetic means, the requirements of the policies and procedures of this Quality
Manual continue to apply (see also 5.4.7).

5.10.8 Format of Reports


Policy:
The format of reports is designed to accommodate each type of test carried out and to
minimize the possibility of misunderstanding or misuse.

Details:
The layout of the test report is such that the presentation of the test data facilitates ease of
assimilation by the reader.

The headings are standardized as far as possible.

5.10.9 Amendments to Reports


Policy:
Material amendments to a test report after issue are made only in the form of a further
document, or data transfer, which includes the statement “Supplement to Test Report, serial
number...[or as otherwise identified]”, or an equivalent form of wording. Such amendments
meet all the requirements in this Quality Manual.

Details:
When it is necessary to issue a complete new test report, it is uniquely identified and
contains a reference to the original that it replaces.

Revision History
Revision 0